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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05813717
• Other study ID #: IM039-1001
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2023
• Est. completion date: October 2, 2023

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986325
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse events		Up to day 92
Primary	Number of participants with clinical laboratory abnormalities		Up to day 64
Primary	Number of participants with vital sign abnormalities		Up to day 64
Primary	Number of participants with ECG abnormalities		Up to day 64
Primary	Number of participants with physical examination abnormalities		Up to day 64
Secondary	Serum concentrations of BMS-986325		Up to day 64
Secondary	Maximum observed serum concentration (Cmax)		Up to day 64
Secondary	Time of maximum observed serum concentration (Tmax)		Up to day 64
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))		Up to day 64
Secondary	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
Secondary	Absolute Bioavailability (F) of BMS-986325	Measured as a percentage	Up to day 64
Secondary	Number of Participants With Anti-Drug Antibody Response		Up to day 64

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls