A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
NCT ID: NCT04736134
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
88 participants
INTERVENTIONAL
2021-03-03
2024-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment (BMS 986326) IV
Intravenous (IV)
BMS-986326
Specified dose on specified days
Active Treatment (BMS 986326) SC
Subcutaneous (SC)
BMS-986326
Specified dose on specified days
Placebo IV
Placebo matching BMS-986326
Specified dose on specified days
Placebo SC
Placebo matching BMS-986326
Specified dose on specified days
Multiple Ascending Dose Placebo SC
Placebo
Multiple Ascending Dose Placebo
Specified dose on specified days
Multiple Ascending Dose SC
BMS 986326 SC
Multiple Ascending Dose SC
Specified dose on specified days
Interventions
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BMS-986326
Specified dose on specified days
Placebo matching BMS-986326
Specified dose on specified days
Multiple Ascending Dose SC
Specified dose on specified days
Multiple Ascending Dose Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening
* 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
* 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)
* Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
* History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
* 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
* History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products
18 Years
50 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Berlin, , Germany
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-002763-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1252-7566
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM034-001
Identifier Type: -
Identifier Source: org_study_id
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