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BMS-986446

Phase 1

Healthy Volunteer | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 1, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06955741A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy ParticipantsPHASE1 COMPLETED 46 — — May 5, 2025Sep 11, 2025Oct 1, 20252 United States
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Study Endpoints
Primary Endpoints
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
Up to approximately Day 85
Secondary Endpoints
Number of Participants With Adverse Events (AEs)
Up to approximately Day 85
Number of Participants With Serious Adverse Events (SAEs)
Up to approximately Day 85
Number of Participants With AEs Reported Related to BMS-986446
Up to approximately Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986446 IVDRUGSpecified dose on specified days was administered intravenously (IV).
BMS-986446 SCDRUGSpecified dose on specified days was administered subcutaneously (SC).
AcetaminophenDRUGSpecified dose on specified days
LoratadineDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2. * Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations. Exclusion Criteria: *...

Countries:United States
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