A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: BMS-986325

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
• Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.

Exclusion Criteria:

• Any significant acute or chronic medical illness.
• Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort J1	Drug: Placebo; Specified dose on specified days; Drug: BMS-986325; Specified dose on specified days
Experimental: Cohort J2	Drug: Placebo; Specified dose on specified days; Drug: BMS-986325; Specified dose on specified days
Experimental: Cohort J3	Drug: Placebo; Specified dose on specified days; Drug: BMS-986325; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse events	Up to day 92
Number of participants with clinical laboratory abnormalities	Up to day 64
Number of participants with vital sign abnormalities	Up to day 64
Number of participants with ECG abnormalities	Up to day 64
Number of participants with physical examination abnormalities	Up to day 64

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentrations of BMS-986325		Up to day 64
Maximum observed serum concentration (Cmax)		Up to day 64
Time of maximum observed serum concentration (Tmax)		Up to day 64
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))		Up to day 64
Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation	Receptor occupancy assays are measured by BMS-986325 binding with fluorescently conjugated antibodies on B cells. Receptor occupancy is calculated as a ratio of fluorescence intensity using unchallenged samples over fluorescence intensity using saturated samples.	Up to day 64
Absolute Bioavailability (F) of BMS-986325	Measured as a percentage	Up to day 64
Number of Participants With Anti-Drug Antibody Response		Up to day 64

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
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IM039-1001

Drug and device information, study documents

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