A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
- Registration Number
- NCT05813717
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort J3 BMS-986325 - Cohort J1 Placebo - Cohort J2 BMS-986325 - Cohort J2 Placebo - Cohort J3 Placebo - Cohort J1 BMS-986325 -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse events Up to day 92 Number of participants with ECG abnormalities Up to day 64 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 physical examination abnormalities Up to day 64
- Secondary Outcome Measures
Name Time Method Serum concentrations of BMS-986325 Up to day 64 Maximum observed serum concentration (Cmax) Up to day 64 Absolute Bioavailability (F) of BMS-986325 Up to day 64 Measured as a percentage
Time of maximum observed serum concentration (Tmax) Up to day 64 Number of Participants With Anti-Drug Antibody Response 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 Up to day 64 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.
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Cypress, California, United States