Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
Interventions
DRUGBMS-986325
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute Bioavailability (F) of BMS-986325 | Up to day 64 | Measured as a percentage |
| Serum concentrations of BMS-986325 | Up to day 64 | — |
| Number of Participants With Anti-Drug Antibody Response | 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 | 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. |
Countries
United States
Outcome results
None listed