Viewing Study NCT03728634

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Ignite Creation Date: 2025-12-25 @ 2:32 AM
Ignite Modification Date: 2026-01-07 @ 2:21 AM
Study NCT ID: NCT03728634
Status: COMPLETED
Last Update Posted: 2022-12-19
First Post: 2018-10-31
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluate the Safety and Tolerability, as Well as the Pharmacokinetic and Pharmacodynamic Profiles of Single and Multiple Doses of Eplontersen Administered Subcutaneously to Healthy Volunteers and Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730926', 'term': 'eplontersen'}, {'id': 'D014801', 'term': 'Vitamin A'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patients@ionisph.com', 'phone': '800-679-4747', 'title': 'Ionis Pharmaceuticals, Inc.', 'organization': 'Ionis Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 176', 'description': 'Safety Set included all randomized participants who received at least 1 injection of study drug (ION-682884 or placebo).', 'eventGroups': [{'id': 'EG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884,120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vessel puncture site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 176', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE was considered related to the medicinal (investigational) product. An AE was to be regarded as a TEAE if it was present prior to receiving the first dose of study drug and subsequently worsened or was not present prior to receiving the first dose of study drug but subsequently appeared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all randomized participants who receive at least 1 injection of study drug (ION-682884 or placebo).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Using Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '22.2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 176', 'description': 'A concomitant therapy was any non-protocol-specified drug or substance (including over-the-counter \\[OTC\\] medications, herbal medications, and vitamin supplements) administered between signing of informed consent and the last study visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all randomized participants who receive at least 1 injection of study drug (ION-682884 or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A 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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 176', 'description': "Laboratory parameters included measurement of blood chemistry, hematology, coagulation, complement, or urinalysis parameters for the single-dose and multiple-dose cohorts. Number of participants with clinically significant values in laboratory based on Investigator's assessment are reported. Any value outside the normal range was to be flagged for the attention of the investigator was to assess whether or not a flagged value is of clinical significance.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all randomized participants who receive at least 1 injection of study drug (ION-682884 or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A 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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 176', 'description': "Physical examination included measurement of height and weight for body mass index (BMI) determination. Number of participants with clinically significant findings in physical examination based on Investigator's assessment are reported. Any value outside the normal range was to be flagged for the attention of the investigator was to assess whether or not a flagged value is of clinical significance.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all randomized participants who receive at least 1 injection of study drug (ION-682884 or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A 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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 176', 'description': "ECG measurements included assessment of ventricular rate (VR), PR interval, QR interval, QT interval, QT corrected using Fridericia's formula (QTcF), and QT corrected using Bazett's formula (QTcB). Number of participants with clinically significant values in electrocardiogram based on Investigator's assessment are reported. Any value outside the normal range was to be flagged for the attention of the investigator was to assess whether or not a flagged value is of clinical significance.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all randomized participants who receive at least 1 injection of study drug (ION-682884 or placebo).'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Drug Concentration of ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.143', 'spread': '39.3', 'groupId': 'OG000'}, {'value': '0.239', 'spread': '62.6', 'groupId': 'OG001'}, {'value': '0.332', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '0.542', 'spread': '65.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.215', 'spread': '66.1', 'groupId': 'OG000'}, {'value': '0.282', 'spread': '74.5', 'groupId': 'OG001'}, {'value': '0.471', 'spread': '69.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Days 1 and 85', 'unitOfMeasure': 'micrograms per milliters (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.01', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '12.0'}, {'value': '2.25', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '8.00'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Days 1 and 85', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Plasma Concentration-Time Curve From Time Zero to Time t for ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.78', 'spread': '20.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '43.2', 'groupId': 'OG001'}, {'value': '4.35', 'spread': '43.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From 0 to 672 hours post-dose on Day 85 for Cohorts A, B, and E; 0 hours to extrapolation to infinity post-dose on Day 1 for Cohort C', 'unitOfMeasure': 'micrograms*hour per milliliter (µg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. Overall number analyzed are the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'CL/F: Apparent Total Clearance of ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '20.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.8', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '43.2', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '43.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From 0 to 672 hours post-dose on Day 85 for Cohorts A, B, and E; 0 hours to extrapolation to infinity post-dose on Day 1 for Cohort C', 'unitOfMeasure': 'liters per hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. Overall number analyzed are the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 't1/2λz: Termination Half-Life of ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '40.7'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '52.7'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '58.9'}, {'value': '24.8', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '45.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 92 hours; post-dose on Day 85 for Cohorts A, B, and E, and on Day 1 for Cohort C', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. Number analyzed is the number of participants with data available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Ae0-24h: Amount of Administered Dose of ION-TTR-LRx Excreted in Urine Over a 24-Hour Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '54.1', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '62.3', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '146', 'groupId': 'OG002'}, {'value': '87.4', 'spread': '87.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40.6', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '68.3', 'spread': '57.2', 'groupId': 'OG001'}, {'value': '133', 'spread': '33.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From 0 to 24 hours post-dose on Days 1 and 85', 'unitOfMeasure': 'micrograms (μg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. Number analyzed is the number of participants with data available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Transthyretin (TTR) Levels Following Single and Multiple-dose Administration of ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.225', 'spread': '2.935', 'groupId': 'OG000'}, {'value': '-13.40', 'spread': '4.312', 'groupId': 'OG001'}, {'value': '-18.63', 'spread': '4.933', 'groupId': 'OG002'}, {'value': '-19.42', 'spread': '5.441', 'groupId': 'OG003'}, {'value': '0.725', 'spread': '1.732', 'groupId': 'OG004'}, {'value': '-20.06', 'spread': '3.615', 'groupId': 'OG005'}]}]}, {'title': 'Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.908', 'spread': '4.050', 'groupId': 'OG000'}, {'value': '-18.60', 'spread': '2.911', 'groupId': 'OG001'}, {'value': '-22.02', 'spread': '3.564', 'groupId': 'OG002'}, {'value': '-21.91', 'spread': '5.175', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg', 'statisticalMethod': 'Analysis of Variance(ANOVA)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.036', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Change From Baseline in Plasma TTR Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 99', 'unitOfMeasure': 'milligrams per deciliters (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 injection of study drug (ION-682884 or placebo). Number analyzed is the number of participants with data available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Retinol Binding Protein 4 (RBP4) Levels Following Single and Multiple-Dose Administration of ION-TTR-LRx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'OG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'OG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '69', 'spread': '5404', 'groupId': 'OG000'}, {'value': '-19317', 'spread': '8459', 'groupId': 'OG001'}, {'value': '-16383', 'spread': '5191', 'groupId': 'OG002'}, {'value': '-21961', 'spread': '8264', 'groupId': 'OG003'}, {'value': '1786', 'spread': '623', 'groupId': 'OG004'}, {'value': '-24765', 'spread': '7020', 'groupId': 'OG005'}]}]}, {'title': 'Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '171', 'spread': '4311', 'groupId': 'OG000'}, {'value': '-28693', 'spread': '6132', 'groupId': 'OG001'}, {'value': '-20124', 'spread': '3946', 'groupId': 'OG002'}, {'value': '-25365', 'spread': '7275', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.036', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Change From Baseline in Plasma RBP4 Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg', 'statisticalMethod': 'Wilcoxon Rank Sum Exact Test (2-sided)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 99', 'unitOfMeasure': 'micrograms per milliliters (µg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 injection of study drug (ION-682884 or placebo). Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Abundance of ION-682884 Antisense Oligonucleotide (ASO) Species (Metabolite) Following Administration of ION-682884 90 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'spread': '1.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours post-dose on Day 85', 'description': 'As prespecified in the protocol, this outcome measure was planned to be analyzed only in the Multiple Dose Cohort B: 90 mg ION-682884.', 'unitOfMeasure': 'percent abundance of ION-682884 ASO', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included all participants who were randomized, received at least 1 dose of ION-682884, and had at least 1 evaluable PK sample. As prespecified in the protocol, this outcome measure was planned to be analyzed in healthy participants administered with 90 mg ION-682884 Q4W for 13 weeks i.e., in the Multiple Dose Cohort B: 90 mg ION-682884.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, subcutaneously (SC), once every 4 weeks \\[Q4W\\] (total of 4 doses) along with daily oral supplemental doses of the recommended daily allowance (RDA) of vitamin A during the 13-week Treatment Period.'}, {'id': 'FG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'FG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'FG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'FG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'FG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'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'}]}]}], 'preAssignmentDetails': 'A total of 47 participants were enrolled, of which 36 were randomized in multiple-dose cohorts and 11 in single-dose cohorts. This study consisted of a single-dose on Day 1, and 13 weeks of Post-Treatment Follow-up for participants in Cohort C and a 12-week Treatment Period followed by 13-week Post Treatment Evaluation Period for participants in Cohorts A, B, and E. Due to limited number of suitable participants with hereditary transthyretin amyloidosis (hATTR), Cohort D was never initiated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'BG001', 'title': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'BG002', 'title': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'BG003', 'title': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.'}, {'id': 'BG004', 'title': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'BG005', 'title': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'groupId': 'BG000', 'lowerLimit': '39.0', 'upperLimit': '57.0'}, {'value': '51.6', 'groupId': 'BG001', 'lowerLimit': '28.0', 'upperLimit': '61.0'}, {'value': '51.6', 'groupId': 'BG002', 'lowerLimit': '23.0', 'upperLimit': '65.0'}, {'value': '51.1', 'groupId': 'BG003', 'lowerLimit': '28.0', 'upperLimit': '62.0'}, {'value': '57.0', 'groupId': 'BG004', 'lowerLimit': '53.0', 'upperLimit': '61.0'}, {'value': '43.4', 'groupId': 'BG005', 'lowerLimit': '26.0', 'upperLimit': '60.0'}, {'value': '49.84', 'groupId': 'BG006', 'lowerLimit': '23.0', 'upperLimit': '65.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Set included all randomized participants who received at least 1 injection of study drug (ION-682884 or placebo).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-06', 'size': 4464718, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-23T16:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2018-10-31', 'resultsFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-23', 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Up to Day 176', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE was considered related to the medicinal (investigational) product. An AE was to be regarded as a TEAE if it was present prior to receiving the first dose of study drug and subsequently worsened or was not present prior to receiving the first dose of study drug but subsequently appeared.'}, {'measure': 'Percentage of Participants Using Concomitant Medications', 'timeFrame': 'Up to Day 176', 'description': 'A concomitant therapy was any non-protocol-specified drug or substance (including over-the-counter \\[OTC\\] medications, herbal medications, and vitamin supplements) administered between signing of informed consent and the last study visit.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Values', 'timeFrame': 'Up to Day 176', 'description': "Laboratory parameters included measurement of blood chemistry, hematology, coagulation, complement, or urinalysis parameters for the single-dose and multiple-dose cohorts. Number of participants with clinically significant values in laboratory based on Investigator's assessment are reported. Any value outside the normal range was to be flagged for the attention of the investigator was to assess whether or not a flagged value is of clinical significance."}, {'measure': 'Number of Participants With Clinically Significant Physical Examination Findings', 'timeFrame': 'Up to Day 176', 'description': "Physical examination included measurement of height and weight for body mass index (BMI) determination. Number of participants with clinically significant findings in physical examination based on Investigator's assessment are reported. Any value outside the normal range was to be flagged for the attention of the investigator was to assess whether or not a flagged value is of clinical significance."}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Values', 'timeFrame': 'Up to Day 176', 'description': "ECG measurements included assessment of ventricular rate (VR), PR interval, QR interval, QT interval, QT corrected using Fridericia's formula (QTcF), and QT corrected using Bazett's formula (QTcB). Number of participants with clinically significant values in electrocardiogram based on Investigator's assessment are reported. Any value outside the normal range was to be flagged for the attention of the investigator was to assess whether or not a flagged value is of clinical significance."}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Drug Concentration of ION-TTR-LRx', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Days 1 and 85'}, {'measure': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of ION-TTR-LRx', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Days 1 and 85'}, {'measure': 'AUCt: Area Under the Plasma Concentration-Time Curve From Time Zero to Time t for ION-TTR-LRx', 'timeFrame': 'From 0 to 672 hours post-dose on Day 85 for Cohorts A, B, and E; 0 hours to extrapolation to infinity post-dose on Day 1 for Cohort C'}, {'measure': 'CL/F: Apparent Total Clearance of ION-TTR-LRx', 'timeFrame': 'From 0 to 672 hours post-dose on Day 85 for Cohorts A, B, and E; 0 hours to extrapolation to infinity post-dose on Day 1 for Cohort C'}, {'measure': 't1/2λz: Termination Half-Life of ION-TTR-LRx', 'timeFrame': 'Up to 92 hours; post-dose on Day 85 for Cohorts A, B, and E, and on Day 1 for Cohort C'}, {'measure': 'Ae0-24h: Amount of Administered Dose of ION-TTR-LRx Excreted in Urine Over a 24-Hour Period', 'timeFrame': 'From 0 to 24 hours post-dose on Days 1 and 85'}, {'measure': 'Change From Baseline in Plasma Transthyretin (TTR) Levels Following Single and Multiple-dose Administration of ION-TTR-LRx', 'timeFrame': 'Baseline, Days 29 and 99'}, {'measure': 'Change From Baseline in Plasma Retinol Binding Protein 4 (RBP4) Levels Following Single and Multiple-Dose Administration of ION-TTR-LRx', 'timeFrame': 'Baseline, Days 29 and 99'}, {'measure': 'Percent Abundance of ION-682884 Antisense Oligonucleotide (ASO) Species (Metabolite) Following Administration of ION-682884 90 mg', 'timeFrame': '2 hours post-dose on Day 85', 'description': 'As prespecified in the protocol, this outcome measure was planned to be analyzed only in the Multiple Dose Cohort B: 90 mg ION-682884.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'hATTR Amyloidosis']}, 'referencesModule': {'references': [{'pmid': '35869634', 'type': 'DERIVED', 'citation': 'Diep JK, Yu RZ, Viney NJ, Schneider E, Guo S, Henry S, Monia B, Geary R, Wang Y. Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis. Br J Clin Pharmacol. 2022 Dec;88(12):5389-5398. doi: 10.1111/bcp.15468. Epub 2022 Aug 7.'}, {'pmid': '33283485', 'type': 'DERIVED', 'citation': 'Viney NJ, Guo S, Tai LJ, Baker BF, Aghajan M, Jung SW, Yu RZ, Booten S, Murray H, Machemer T, Burel S, Murray S, Buchele G, Tsimikas S, Schneider E, Geary RS, Benson MD, Monia BP. Ligand conjugated antisense oligonucleotide for the treatment of transthyretin amyloidosis: preclinical and phase 1 data. ESC Heart Fail. 2021 Feb;8(1):652-661. doi: 10.1002/ehf2.13154. Epub 2020 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability, as well as the pharmacokinetic and pharmacodynamic profiles of single and multiple doses of Eplontersen administered subcutaneously to healthy volunteers and patients with Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).', 'detailedDescription': 'This will be a Phase 1/2, double-blind, randomized, placebo-controlled, dose-escalation study conducted at a single center for the healthy volunteer cohorts in up to 56 participants. It will consist of 1 single-dose cohort and 3 multiple-dose cohorts (n = 12 per cohort, 10 active:2 placebo). The open-label, hATTR patient cohort portion of the study will be conducted at multiple centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Healthy Volunteers (Cohorts A, B, C, and E)\n\n1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal\n2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method\n3. Weight ≥ 50 kg and BMI \\< 32 kg/m\\^2\n\nExclusion Criteria for Healthy Volunteers (Cohorts A, B, C, and E)\n\n1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion including abnormal safety labs\n2. Drug or alcohol dependency or abuse\n3. Treatment with another investigational drug, biological agent, or device within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer\n4. Blood donation within 28 days\n5. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study\n\nInclusion Criteria for hATTR Patients (Cohort D)\n\n1. Aged 18 to 82 years at the time of informed consent\n2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal\n3. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method\n4. Diagnosis of hereditary transthyretin-mediated polyneuropathy\n5. BMI \\> 16 kg/m2\n\nExclusion Criteria for hATTR Patients (Cohort D)\n\n1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to abnormal safety labs\n2. Karnofsky performance status ≤ 50\n3. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease), including uncontrolled diabetes\n4. Prior liver transplant or anticipated liver transplant within 1-yr of Screening\n5. New York Heart Association (NYHA) functional classification of ≥ 3\n6. Acute coronary syndrome or major surgery within 3 months of Screening\n7. Other types of amyloidosis\n8. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study"}, 'identificationModule': {'nctId': 'NCT03728634', 'briefTitle': 'Evaluate the Safety and Tolerability, as Well as the Pharmacokinetic and Pharmacodynamic Profiles of Single and Multiple Doses of Eplontersen Administered Subcutaneously to Healthy Volunteers and Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'This Was a Phase 1/2, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study Conducted at a Single Center for the Healthy Volunteer Cohorts in up to 56 Participants. It Consisted of 1 Single-dose Cohort and 3 Multiple-dose Cohorts (n = 12 Per Cohort, 10 Active:2 Placebo). The Open-label, hATTR Patient Cohort Portion of the Study Was Conducted at Multiple Centers.', 'orgStudyIdInfo': {'id': 'ION-682884-CS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Multiple Dose Cohort: Placebo', 'description': 'Participants received ION-682884 matching placebo, subcutaneously (SC) once every 4 weeks \\[Q4W\\] (total of 4 doses) along with daily oral supplemental doses of the recommended daily allowance (RDA) of vitamin A during the 13-week Treatment Period.', 'interventionNames': ['Drug: Placebo', 'Dietary Supplement: Vitamin A']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose Cohort A: ION-682884 45 mg', 'description': 'Participants received ION-682884, 45 milligrams (mg), SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'interventionNames': ['Drug: ION-682884', 'Dietary Supplement: Vitamin A']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose Cohort E: ION-682884 60 mg', 'description': 'Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'interventionNames': ['Drug: ION-682884', 'Dietary Supplement: Vitamin A']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose Cohort B: ION-682884 90 mg', 'description': 'Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period.', 'interventionNames': ['Drug: ION-682884', 'Dietary Supplement: Vitamin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single Dose Cohort: Placebo', 'description': 'Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.', 'interventionNames': ['Drug: Placebo', 'Dietary Supplement: Vitamin A']}, {'type': 'EXPERIMENTAL', 'label': 'Single Dose Cohort C: ION-682884 120 mg', 'description': 'Participants received single dose of ION-682884, 120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1.', 'interventionNames': ['Drug: ION-682884', 'Dietary Supplement: Vitamin A']}], 'interventions': [{'name': 'ION-682884', 'type': 'DRUG', 'otherNames': ['Eplontersen', 'AKCEA-TTR-LRx', 'IONIS-TTR-LRx'], 'description': 'ION-682884 administered SC', 'armGroupLabels': ['Multiple Dose Cohort A: ION-682884 45 mg', 'Multiple Dose Cohort B: ION-682884 90 mg', 'Multiple Dose Cohort E: ION-682884 60 mg', 'Single Dose Cohort C: ION-682884 120 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator calculated volume to match ION-682884 administered SC', 'armGroupLabels': ['Multiple Dose Cohort: Placebo', 'Single Dose Cohort: Placebo']}, {'name': 'Vitamin A', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral supplement', 'armGroupLabels': ['Multiple Dose Cohort A: ION-682884 45 mg', 'Multiple Dose Cohort B: ION-682884 90 mg', 'Multiple Dose Cohort E: ION-682884 60 mg', 'Multiple Dose Cohort: Placebo', 'Single Dose Cohort C: ION-682884 120 mg', 'Single Dose Cohort: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M9L 3A2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bio Pharma Services, Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}