The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Cypress, California, United States
Number of participants with Adverse events
Time frame: Up to day 92
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 ECG abnormalities
Time frame: Up to day 64
Number of participants with physical examination abnormalities
Time frame: Up to day 64
Serum concentrations of BMS-986325
Time frame: Up to day 64
Maximum observed serum concentration (Cmax)
Time frame: Up to day 64
Time of maximum observed serum concentration (Tmax)
Time frame: Up to day 64
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: 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.
Time frame: Up to day 64
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Absolute Bioavailability (F) of BMS-986325
Measured as a percentage
Time frame: Up to day 64
Number of Participants With Anti-Drug Antibody Response
Time frame: Up to day 64