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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Biological: BMS-986326; Other: Placebo matching BMS-986326; Other: Multiple Ascending Dose Placebo; Biological: Multiple Ascending Dose SC

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo SC	Other: Placebo matching BMS-986326; Specified dose on specified days
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: Multiple Ascending Dose Placebo SC; Placebo	Other: Multiple Ascending Dose Placebo; Specified dose on specified days
Experimental: Multiple Ascending Dose SC; BMS 986326 SC	Biological: Multiple Ascending Dose SC; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Healthy participants; BMS-986326
• Other Study ID Numbers: IM034-001; 2020-002763-64 (EudraCT Number); U1111-1252-7566 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No