Healthy Participants Clinical Trial
Official title:
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
| Verified date | April 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | March 14, 2024 |
| Est. primary completion date | March 14, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Local Institution - 0001 | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Up to 175 days | ||
| Primary | Number of participants with clinical laboratory abnormalities | Up to 175 days | ||
| Primary | Number of participants with vital sign abnormalities | Up to 175 days | ||
| Primary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 175 days | ||
| Primary | Number of participants with physical examinations abnormalities | Up to 175 days | ||
| Secondary | Maximum observed serum concentration (Cmax) | Up to 175 days | ||
| Secondary | Time of maximum observed serum concentration (Tmax) | Up to 175 days | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Change in regulatory T cells (Treg) count | Up to 175 days | ||
| Secondary | Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio | Up to 175 days | ||
| Secondary | Number of participants with anti-drug antibodies | Up to 175 days |
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