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BMS-986325

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 7, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05813717A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese ParticipantsPHASE1 COMPLETED 25Apr 10, 2023Oct 2, 2023Nov 7, 20231 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
Serum concentrations of BMS-986325
Up to day 64
Maximum observed serum concentration (Cmax)
Up to day 64
Time of maximum observed serum concentration (Tmax)
Up to day 64
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort J1EXPERIMENTAL -
Cohort J2EXPERIMENTAL -
Cohort J3EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986325DRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 de...

Countries:United States
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