Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 6:27 PM
Study NCT ID:
NCT04736134
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 175 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 175 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 175 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 175 days'}, {'measure': 'Number of participants with physical examinations abnormalities', 'timeFrame': 'Up to 175 days'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax)', 'timeFrame': 'Up to 175 days'}, {'measure': 'Time of maximum observed serum concentration (Tmax)', 'timeFrame': 'Up to 175 days'}, {'measure': 'Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to 175 days'}, {'measure': 'Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)]', 'timeFrame': 'Up to 175 days'}, {'measure': 'Change in regulatory T cells (Treg) count', 'timeFrame': 'Up to 175 days'}, {'measure': 'Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio', 'timeFrame': 'Up to 175 days'}, {'measure': 'Number of participants with anti-drug antibodies', 'timeFrame': 'Up to 175 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986326', 'Healthy participants'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good health, as determined by the investigator based on a physical examination at screening\n* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\\^2 at screening\n* Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening\n* Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)\n* Must agree to follow specific methods of contraception, if applicable\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants\n* History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04736134', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM034-001'}, 'secondaryIdInfos': [{'id': '2020-002763-64', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1252-7566', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment (BMS 986326) IV', 'description': 'Intravenous (IV)', 'interventionNames': ['Biological: BMS-986326']}, {'type': 'EXPERIMENTAL', 'label': 'Active Treatment (BMS 986326) SC', 'description': 'Subcutaneous (SC)', 'interventionNames': ['Biological: BMS-986326']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo IV', 'interventionNames': ['Other: Placebo matching BMS-986326']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SC', 'interventionNames': ['Other: Placebo matching BMS-986326']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Multiple Ascending Dose Placebo SC', 'description': 'Placebo', 'interventionNames': ['Other: Multiple Ascending Dose Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Dose SC', 'description': 'BMS 986326 SC', 'interventionNames': ['Biological: Multiple Ascending Dose SC']}], 'interventions': [{'name': 'BMS-986326', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Active Treatment (BMS 986326) IV', 'Active Treatment (BMS 986326) SC']}, {'name': 'Placebo matching BMS-986326', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo IV', 'Placebo SC']}, {'name': 'Multiple Ascending Dose SC', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Multiple Ascending Dose SC']}, {'name': 'Multiple Ascending Dose Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Multiple Ascending Dose Placebo SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}