Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-27 @ 2:36 AM
Study NCT ID:
NCT02601560
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-301-398-5681', 'title': 'Richard George, MD, Director, Clinical Development', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infusion site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Medical device site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'High density lipoprotein decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 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'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 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An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population: All participants who received any amount of study drug were included in this population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs Related to Vital Sign Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs Related to Clinical Laboratory Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population'}, {'type': 'PRIMARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.1', 'spread': '120.0', 'groupId': 'OG000'}, {'value': '728.3', 'spread': '334.2', 'groupId': 'OG001'}, {'value': '1639.9', 'spread': '631.7', 'groupId': 'OG002'}, {'value': '3035.0', 'spread': '439.1', 'groupId': 'OG003'}, {'value': '5318.3', 'spread': '1674.3', 'groupId': 'OG004'}, {'value': '-113.5', 'spread': '289.4', 'groupId': 'OG005'}, {'value': '422.4', 'spread': '395.7', 'groupId': 'OG006'}, {'value': '2844.7', 'spread': '1219.1', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.095', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.440', 'groupIds': ['OG005', 'OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG005', 'OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Population.'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '954.1', 'groupId': 'OG000'}, {'value': '-164.9', 'spread': '1301.5', 'groupId': 'OG001'}, {'value': '1925.7', 'spread': '913.3', 'groupId': 'OG002'}, {'value': '3639.2', 'spread': '667.6', 'groupId': 'OG003'}, {'value': '6990.3', 'spread': '1764.0', 'groupId': 'OG004'}, {'value': '82.3', 'spread': '983.4', 'groupId': 'OG005'}, {'value': '240.9', 'spread': '494.2', 'groupId': 'OG006'}, {'value': '3156.8', 'spread': '1476.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '265.4', 'groupId': 'OG000'}, {'value': '-197.7', 'spread': '338.2', 'groupId': 'OG001'}, {'value': '38.9', 'spread': '346.8', 'groupId': 'OG002'}, {'value': '110.0', 'spread': '133.9', 'groupId': 'OG003'}, {'value': '434.6', 'spread': '541.7', 'groupId': 'OG004'}, {'value': '172.5', 'spread': '76.6', 'groupId': 'OG005'}, {'value': '-61.5', 'spread': '206.6', 'groupId': 'OG006'}, {'value': '-205.4', 'spread': '324.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.6', 'spread': '776.0', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '992.6', 'groupId': 'OG001'}, {'value': '1886.8', 'spread': '722.8', 'groupId': 'OG002'}, {'value': '3529.2', 'spread': '628.3', 'groupId': 'OG003'}, {'value': '6555.7', 'spread': '1674.0', 'groupId': 'OG004'}, {'value': '-90.2', 'spread': '965.4', 'groupId': 'OG005'}, {'value': '302.4', 'spread': '428.4', 'groupId': 'OG006'}, {'value': '3362.3', 'spread': '1340.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.3', 'spread': '108.9', 'groupId': 'OG000'}, {'value': '668.4', 'spread': '263.3', 'groupId': 'OG001'}, {'value': '1460.7', 'spread': '584.0', 'groupId': 'OG002'}, {'value': '2778.0', 'spread': '416.7', 'groupId': 'OG003'}, {'value': '4886.0', 'spread': '1459.7', 'groupId': 'OG004'}, {'value': '-132.6', 'spread': '253.1', 'groupId': 'OG005'}, {'value': '392.7', 'spread': '350.3', 'groupId': 'OG006'}, {'value': '2672.5', 'spread': '1115.7', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '906.4', 'groupId': 'OG000'}, {'value': '-893.2', 'spread': '1316.0', 'groupId': 'OG001'}, {'value': '285.8', 'spread': '1051.8', 'groupId': 'OG002'}, {'value': '604.2', 'spread': '659.1', 'groupId': 'OG003'}, {'value': '1672.0', 'spread': '1413.4', 'groupId': 'OG004'}, {'value': '195.8', 'spread': '809.9', 'groupId': 'OG005'}, {'value': '-181.5', 'spread': '385.1', 'groupId': 'OG006'}, {'value': '312.2', 'spread': '642.4', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV 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'groupId': 'OG003'}, {'value': '417.1', 'spread': '256.1', 'groupId': 'OG004'}, {'value': '19.1', 'spread': '46.6', 'groupId': 'OG005'}, {'value': '29.7', 'spread': '77.5', 'groupId': 'OG006'}, {'value': '172.2', 'spread': '156.6', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '748.1', 'groupId': 'OG000'}, {'value': '-635.6', 'spread': '984.0', 'groupId': 'OG001'}, {'value': '426.1', 'spread': '723.0', 'groupId': 'OG002'}, {'value': '741.6', 'spread': '590.5', 'groupId': 'OG003'}, {'value': '1649.5', 'spread': '1007.5', 'groupId': 'OG004'}, {'value': '42.4', 'spread': '791.6', 'groupId': 'OG005'}, {'value': '-90.3', 'spread': '390.6', 'groupId': 'OG006'}, {'value': '689.8', 'spread': '634.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg 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of non-high density lipoprotein unesterified cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '182.1', 'spread': '600.9', 'groupId': 'OG000'}, {'value': '-473.0', 'spread': '1096.4', 'groupId': 'OG001'}, {'value': '83.2', 'spread': '762.0', 'groupId': 'OG002'}, {'value': '987.2', 'spread': '453.8', 'groupId': 'OG003'}, {'value': '1812.8', 'spread': '1081.8', 'groupId': 'OG004'}, {'value': '-101.6', 'spread': '854.2', 'groupId': 'OG005'}, {'value': '-61.7', 'spread': '438.1', 'groupId': 'OG006'}, {'value': '996.1', 'spread': '803.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '220.7', 'spread': '524.7', 'groupId': 'OG000'}, {'value': '-795.5', 'spread': '695.5', 'groupId': 'OG001'}, {'value': '-636.7', 'spread': '682.6', 'groupId': 'OG002'}, {'value': '-649.5', 'spread': '208.6', 'groupId': 'OG003'}, {'value': '-537.1', 'spread': '706.2', 'groupId': 'OG004'}, {'value': '97.4', 'spread': '483.2', 'groupId': 'OG005'}, {'value': '-309.0', 'spread': '270.5', 'groupId': 'OG006'}, {'value': '-219.0', 'spread': '630.7', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.68', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '1.19', 'groupId': 'OG002'}, {'value': '2.53', 'spread': '1.80', 'groupId': 'OG003'}, {'value': '4.85', 'spread': '4.01', 'groupId': 'OG004'}, {'value': '3.90', 'spread': 'NA', 'comment': 'Standard deviation cannot be determined as only 1 participant was available.', 'groupId': 'OG005'}, {'value': '3.38', 'spread': '1.48', 'groupId': 'OG006'}, {'value': '1.67', 'spread': '0.46', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '0.40', 'spread': '0.62', 'groupId': 'OG003'}, {'value': '-1.12', 'spread': '3.21', 'groupId': 'OG004'}, {'value': '-1.10', 'spread': 'NA', 'comment': 'Standard deviation cannot be determined as only 1 participant was available.', 'groupId': 'OG005'}, {'value': '1.33', 'spread': '1.44', 'groupId': 'OG006'}, {'value': '0.10', 'spread': '0.60', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Day 29', 'description': 'The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1250.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '1250.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1250.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '1250.0', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '1250.0', 'spread': '0.0', 'groupId': 'OG004'}, {'value': '1250.0', 'spread': '0.0', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be determined as only 1 participant was available.', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be determined as only 1 participant was available.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Day 57', 'description': 'The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: All participants in the as-treated population who had atleast one detectable LCAT serum concentration measurement.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.02', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '4.15', 'groupId': 'OG001'}, {'value': '73.5', 'spread': '9.40', 'groupId': 'OG002'}, {'value': '229', 'spread': '55.4', 'groupId': 'OG003'}, {'value': '22.8', 'spread': '9.75', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.', 'unitOfMeasure': 'micrograms/milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\\<2.5 mcg/mL).'}, {'type': 'SECONDARY', 'title': 'Time to Reach Concentration Maximum (Tmax) of MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '2.25', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.00', 'spread': '4.15', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.00', 'spread': '9.40', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'spread': '55.4', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '48.0', 'spread': '9.75', 'groupId': 'OG004', 'lowerLimit': '48.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\\<2.5 mcg/mL).'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'spread': '55.0', 'groupId': 'OG000'}, {'value': '805', 'spread': '265', 'groupId': 'OG001'}, {'value': '2760', 'spread': '249', 'groupId': 'OG002'}, {'value': '8470', 'spread': '2000', 'groupId': 'OG003'}, {'value': '2460', 'spread': '824', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\\<2.5 mcg/mL).'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '42.7', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '683', 'spread': '267', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '2760', 'spread': '249', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '9020', 'spread': '2760', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '2460', 'spread': '824', 'groupId': 'OG004', 'lowerLimit': '48.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUC \\[0-last\\]) of MEDI6012.', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\\<2.5 mcg/mL).'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'spread': '56.1', 'groupId': 'OG000'}, {'value': '887', 'spread': '308', 'groupId': 'OG001'}, {'value': '3030', 'spread': '298', 'groupId': 'OG002'}, {'value': '9510', 'spread': '2720', 'groupId': 'OG003'}, {'value': '3560', 'spread': '732', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The area under the concentration-time curve to infinite time of MEDI6012.', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\\<2.5 mcg/mL).'}, {'type': 'SECONDARY', 'title': 'Elimination Half Life (t1/2) of MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '45.7', 'spread': '3.67', 'groupId': 'OG002'}, {'value': '55.4', 'spread': '14.2', 'groupId': 'OG003'}, {'value': '89.5', 'spread': '46.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The t1/2 is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (\\<2.5 mcg/mL).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibodies for MEDI6012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'OG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'OG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'OG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'classes': [{'title': 'Day 1 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (pre-dose), 15, 29 and 57', 'description': "Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population: All participants in the as-treated population with at least one serum sample available for immunogenicity testing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'FG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'FG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'FG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'FG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'FG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'FG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'FG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 230 participants were screened in the study from 07-Dec-2015 to 13-Jan-2017 at 8 sites in the United States of America.', 'preAssignmentDetails': 'Out of 230 participants, 182 participants were considered screen failures. The remaining 48 participants were randomized to receive the study drug. The 1600 mg dose was omitted based on a greater than expected pharmacodynamics effects at lower doses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'BG001', 'title': 'MEDI6012 24 Milligram (mg) IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.'}, {'id': 'BG002', 'title': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'BG003', 'title': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.'}, {'id': 'BG004', 'title': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.'}, {'id': 'BG005', 'title': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.'}, {'id': 'BG006', 'title': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.'}, {'id': 'BG007', 'title': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '6.4', 'groupId': 'BG002'}, {'value': '63.5', 'spread': '5.4', 'groupId': 'BG003'}, {'value': '65.8', 'spread': '8.2', 'groupId': 'BG004'}, {'value': '62.0', 'spread': '9.3', 'groupId': 'BG005'}, {'value': '71.3', 'spread': '3.4', 'groupId': 'BG006'}, {'value': '66.5', 'spread': '4.7', 'groupId': 'BG007'}, {'value': '64.0', 'spread': '6.9', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As-treated Population: All participants who received any amount of study drug were included in this population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2017-08-01', 'completionDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2015-11-09', 'dispFirstSubmitQcDate': '2017-08-16', 'resultsFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2015-11-09', 'dispFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-16', 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Number of Participants With TEAEs Related to Vital Sign Parameters', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.'}, {'measure': 'Number of Participants With TEAEs Related to Clinical Laboratory Evaluations', 'timeFrame': 'Baseline (Day 1) up to Day 57', 'description': 'An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.'}], 'secondaryOutcomes': [{'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein unesterified cholesterol.'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).'}, {'measure': 'Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B', 'timeFrame': 'Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)', 'description': 'The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.'}, {'measure': 'Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29', 'timeFrame': 'Baseline (Day 1) and Day 29', 'description': 'The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.'}, {'measure': 'Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57', 'timeFrame': 'Baseline (Day 1) and Day 57', 'description': 'The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of MEDI6012', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.'}, {'measure': 'Time to Reach Concentration Maximum (Tmax) of MEDI6012', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.'}, {'measure': 'Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.'}, {'measure': 'Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUC \\[0-last\\]) of MEDI6012.'}, {'measure': 'Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The area under the concentration-time curve to infinite time of MEDI6012.'}, {'measure': 'Elimination Half Life (t1/2) of MEDI6012', 'timeFrame': 'Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)', 'description': 'The t1/2 is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibodies for MEDI6012', 'timeFrame': 'Day 1 (pre-dose), 15, 29 and 57', 'description': "Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'CAD'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34121413', 'type': 'DERIVED', 'citation': 'George RT, Abuhatzira L, Stoughton SM, Karathanasis SK, She D, Jin C, Buss NAPS, Bakker-Arkema R, Ongstad EL, Koren M, Hirshberg B. MEDI6012: Recombinant Human Lecithin Cholesterol Acyltransferase, High-Density Lipoprotein, and Low-Density Lipoprotein Receptor-Mediated Reverse Cholesterol Transport. J Am Heart Assoc. 2021 Jul 6;10(13):e014572. doi: 10.1161/JAHA.119.014572. Epub 2021 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 40 - 75 years old\n* History of Stable CAD\n* Currently receiving statin as standard of care\n\nExclusion Criteria:\n\n* Severe angina pectoris symptoms\n* High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period\n* Hospitalization for heart failure within 12 months prior to screening\n* Uncontrolled Hypertension\n* Within 6 months prior to screening, a history of ACS or hospitalization for heart failure\n* Clinically significant abnormalities in rhythm, conduction or morphology of ECG\n* Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy\n* Untreated life-threatening ventricular arrhythmias\n* History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease\n* Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period'}, 'identificationModule': {'nctId': 'NCT02601560', 'briefTitle': 'To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- Ascending Doses of MEDI6012 in Subjects With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'D5780C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI6012 24 mg IV', 'description': 'Participants received a single IV dose of 24 mg MEDI6012 on Day 1.', 'interventionNames': ['Biological: MEDI6012']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI6012 80 mg IV', 'description': 'Participants received a single IV dose of 80 mg MEDI6012 on Day 1.', 'interventionNames': ['Biological: MEDI6012']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI6012 240 mg IV', 'description': 'Participants received a single IV dose of 240 mg MEDI6012 on Day 1.', 'interventionNames': ['Biological: MEDI6012']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI6012 800 mg IV', 'description': 'Participants received a single IV dose of 800 mg MEDI6012 on Day 1.', 'interventionNames': ['Biological: MEDI6012']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI6012 80 mg SC', 'description': 'Participants received a single SC dose of 80 mg MEDI6012 on Day 1.', 'interventionNames': ['Biological: MEDI6012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Intravenous (IV)', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.', 'interventionNames': ['Biological: Placebo IV']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI6012 600 mg SC', 'description': 'Participants received a single SC dose of 600 mg MEDI6012 on Day 1.', 'interventionNames': ['Biological: MEDI6012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Subcutaneous (SC)', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.', 'interventionNames': ['Biological: Placebo SC']}], 'interventions': [{'name': 'MEDI6012', 'type': 'BIOLOGICAL', 'description': 'Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.', 'armGroupLabels': ['MEDI6012 24 mg IV', 'MEDI6012 240 mg IV', 'MEDI6012 600 mg SC', 'MEDI6012 80 mg IV', 'MEDI6012 80 mg SC', 'MEDI6012 800 mg IV']}, {'name': 'Placebo SC', 'type': 'BIOLOGICAL', 'description': 'Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.', 'armGroupLabels': ['Placebo Subcutaneous (SC)']}, {'name': 'Placebo IV', 'type': 'BIOLOGICAL', 'description': 'Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.', 'armGroupLabels': ['Placebo Intravenous (IV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}