A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Biological: BMS-986326Other: Placebo matching BMS-986326Biological: Multiple Ascending Dose SCOther: Multiple Ascending Dose Placebo
- Registration Number
- NCT04736134
- Lead Sponsor
- Bristol-Myers Squibb
- 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, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
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 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Active Treatment (BMS 986326) IV BMS-986326 Intravenous (IV) Active Treatment (BMS 986326) SC BMS-986326 Subcutaneous (SC) Placebo IV Placebo matching BMS-986326 - Placebo SC Placebo matching BMS-986326 - Multiple Ascending Dose SC Multiple Ascending Dose SC BMS 986326 SC Multiple Ascending Dose Placebo SC Multiple Ascending Dose Placebo Placebo
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 175 days Number of participants with physical examinations abnormalities Up to 175 days Number of participants with clinical laboratory abnormalities Up to 175 days Number of participants with vital sign abnormalities Up to 175 days Number of participants with electrocardiogram (ECG) abnormalities Up to 175 days
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) Up to 175 days Time of maximum observed serum concentration (Tmax) Up to 175 days Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio Up to 175 days Number of participants with anti-drug antibodies Up to 175 days Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] Up to 175 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 175 days Change in regulatory T cells (Treg) count Up to 175 days
Trial Locations
- Locations (1)
Local Institution - 0001
🇩🇪Berlin, Germany