A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Biological: BMS-986326
* Other: Placebo matching BMS-986326
* Biological: Multiple Ascending Dose SC
* Other: Multiple Ascending Dose Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment (BMS 986326) IV<br>Intravenous (IV) | Biological: BMS-986326<br>* Specified dose on specified days<br>|
| Experimental: Active Treatment (BMS 986326) SC<br>Subcutaneous (SC) | Biological: BMS-986326<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo IV<br> | Other: Placebo matching BMS-986326<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo SC<br> | Other: Placebo matching BMS-986326<br>* Specified dose on specified days<br>|
| Placebo Comparator: Multiple Ascending Dose Placebo SC<br>Placebo | Other: Multiple Ascending Dose Placebo<br>* Specified dose on specified days<br>|
| Experimental: Multiple Ascending Dose SC<br>BMS 986326 SC | Biological: Multiple Ascending Dose SC<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | 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 | 
| Number of participants with physical examinations abnormalities |  | Up to 175 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Up to 175 days | 
| Time of maximum observed serum concentration (Tmax) |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986326, Healthy participants