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

Bristol-Myers Squibb1 site in 1 country88 target enrollmentMarch 3, 2021

ConditionsHealthy Participants

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Participants
Sponsor: Bristol-Myers Squibb
Enrollment: 88
Locations: 1
Primary Endpoint: Number of participants with adverse events (AEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 3, 2021

End Date

March 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility 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 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

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Time Frame: Up to 175 days

Number of participants with physical examinations abnormalities

Time Frame: Up to 175 days

Number of participants with clinical laboratory abnormalities

Time Frame: Up to 175 days

Number of participants with vital sign abnormalities

Time Frame: Up to 175 days

Number of participants with electrocardiogram (ECG) abnormalities

Time Frame: Up to 175 days

Secondary Outcomes

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)