A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
Study Details
Study Description
Brief Summary
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 and frequency for future studies of BMS-986326 in participants with immune-mediated diseases.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Active Treatment (BMS 986326) IV Intravenous (IV) |
Biological: BMS-986326
Specified dose on specified days
|
Experimental: Active Treatment (BMS 986326) SC Subcutaneous (SC) |
Biological: BMS-986326
Specified dose on specified days
|
Placebo Comparator: Placebo IV
|
Other: Placebo matching BMS-986326
Specified dose on specified days
|
Placebo Comparator: Placebo SC
|
Other: Placebo matching BMS-986326
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs) [Up to 119 days]
- Number of participants with clinical laboratory abnormalities [Up to 119 days]
- Number of participants with vital sign abnormalities [Up to 119 days]
- Number of participants with electrocardiogram (ECG) abnormalities [Up to 119 days]
- Number of participants with physical examinations abnormalities [Up to 119 days]
Secondary Outcome Measures
- Maximum observed serum concentration (Cmax) [Up to 119 days]
- Time of maximum observed serum concentration (Tmax) [Up to 119 days]
- Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] [Up to 119 days]
- Geometric mean ratios of test (SC) vs reference (IV): Cmax [Up to 119 days]
- Geometric mean ratios of test (SC) vs reference (IV): AUC(0-T) [Up to 119 days]
- Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)] [Up to 119 days]
- Change in regulatory T cells (Treg) count [Up to 119 days]
- Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio [Up to 119 days]
- Number of participants with anti-drug antibodies [Up to 119 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
In good health, as determined by the investigator based on a physical examination at screening
-
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 and women not of child-bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3). Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3)
-
Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
-
Women who are pregnant or lactating
-
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
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution - 0001 | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IM034-001
- 2020-002763-64
- U1111-1252-7566