Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-19 @ 11:04 AM
Study NCT ID:
NCT03058458
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with TEAEs and number of events will be summarised by treatment', 'timeFrame': '21 days', 'description': 'Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.', 'timeFrame': '14 days', 'description': 'Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after single and multiple dose administration and repeated until Day 14.'}, {'measure': 'Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.', 'timeFrame': '14 days', 'description': 'Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after single and multiple dose administration and repeated until Day 14.'}, {'measure': 'Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.', 'timeFrame': '14 days', 'description': 'RR-interval, PR (PQ)-interval, QRS-duration, QT-interval, QTcB, QTcF and heart rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14.'}, {'measure': 'Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.', 'timeFrame': '14 days', 'description': 'Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14.'}, {'measure': 'Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)', 'timeFrame': '24 hours', 'description': 'Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104'}, {'measure': 'PK of PIN201104: The time to reach Cmax (Tmax)', 'timeFrame': '24 hours', 'description': 'Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104'}, {'measure': 'PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)', 'timeFrame': '24 hours', 'description': 't1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104'}, {'measure': 'PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)', 'timeFrame': '24 hours', 'description': 'AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104'}, {'measure': 'PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)', 'timeFrame': '24 hours', 'description': 'CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104'}, {'measure': 'PK of PIN201104: Apparent volume of distribution (Vz/F)', 'timeFrame': '24 hours', 'description': 'Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects of non-childbearing potential age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.\n* Written informed consent must be obtained before any assessment is performed.\n* Able to communicate well with the Investigator/designee.\n\nExclusion Criteria:\n\n* Any known reaction to study drug or components\n* concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs\n* No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening\n* Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.\n* Excessive use of caffeine-containing beverages\n* Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.\n* History of regular alcohol consumption within 6 months of screening 10.\n* Positive screen for drugs-of-abuse or cotinine.\n* Blood donation in excess of 500mL within 3 months.\n* Participation in another study with an experimental drug within 3 months of first IMP administration.\n* Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.\n* Ongoing rhinitis that requires treatment.\n* Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine 14 days before dosing with study drug until telephone follow-up.'}, 'identificationModule': {'nctId': 'NCT03058458', 'briefTitle': 'A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peptinnovate'}, 'officialTitle': 'A First-time-in-human, Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Healthy Volunteers and Patients With Asthma to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of PIN201104', 'orgStudyIdInfo': {'id': 'C1104-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD PIN201104 in Healthy Volunteers (HV)', 'description': 'PIN201104 or placebo IV administration, single dose, 10 dose cohorts', 'interventionNames': ['Drug: PIN201104', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Repeat dose PIN201104 in HV', 'description': 'PIN201104 or placebo IV administration, 3 doses on single day, 1 cohort', 'interventionNames': ['Drug: PIN201104', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose PIN201104 in asthma patients', 'description': 'PIN201104 or placebo IV administration, single dose, 2 cohorts', 'interventionNames': ['Drug: PIN201104', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single SC dose in HV', 'description': 'PIN201104 or placebo SC administration, single dose, 1 cohort', 'interventionNames': ['Drug: PIN201104', 'Drug: Placebo']}], 'interventions': [{'name': 'PIN201104', 'type': 'DRUG', 'description': 'IV or SC administration', 'armGroupLabels': ['Repeat dose PIN201104 in HV', 'SAD PIN201104 in Healthy Volunteers (HV)', 'Single SC dose in HV', 'Single dose PIN201104 in asthma patients']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV or SC administration', 'armGroupLabels': ['Repeat dose PIN201104 in HV', 'SAD PIN201104 in Healthy Volunteers (HV)', 'Single SC dose in HV', 'Single dose PIN201104 in asthma patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Investigator Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Muna Albayaty, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peptinnovate', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}