NCT05813717CompletedPhase 1
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
Bristol-Myers Squibb1 site in 1 country25 target enrollmentStarted: April 10, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cohort J1
Experimental
Intervention: BMS-986325 (Drug)
Cohort J1
Experimental
Intervention: Placebo (Drug)
Cohort J2
Experimental
Intervention: BMS-986325 (Drug)
Cohort J2
Experimental
Intervention: Placebo (Drug)
Cohort J3
Experimental
Intervention: BMS-986325 (Drug)
Cohort J3
Experimental
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with Adverse events
Time Frame: Up to day 92
Number of participants with ECG abnormalities
Time Frame: Up to day 64
Number of participants with clinical laboratory abnormalities
Time Frame: Up to day 64
Number of participants with vital sign abnormalities
Time Frame: Up to day 64
Number of participants with physical examination abnormalities
Time Frame: Up to day 64
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (1)
Loading locations...
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