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BMS-986447

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Apr 5, 2024

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05760937A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy ParticipantsPHASE1 COMPLETED 32 — — Mar 10, 2023Nov 27, 2023Apr 5, 20241 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs)
Up to 59 days
Number of Participants with Serious AEs (SAEs)
Up to 59 days
Number of Participants with Clinical Laboratory Abnormalities
Up to 34 days
Number of Participants with Vital Sign Abnormalities
Up to 35 days
Number of Participants with Physical Examination Abnormalities
Up to 35 days
Number of Participants with Electrocardiogram (ECG) Abnormalities
Up to 34 days
Secondary Endpoints
Maximum observed plasma concentration (Cmax)
Up to 72 hours postdose
Time of maximum observed plasma concentration (Tmax)
Up to 72 hours postdose
Apparent terminal phase half-life (T-Half)
Up to 72 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986447EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-986447DRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index between 18 and 30 kilograms per metered square (kg/m\^2), inclusive. * Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations. * A negative ...

Countries:United States
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