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BMS-986235

Phase 1

Mediators of Inflammation | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Mar 31, 2022

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 Enrollment122
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03335553A Study of Experimental Medication BMS-986235 in Healthy SubjectsPHASE1 COMPLETED 122 — — Nov 15, 2017Jul 2, 2021Mar 31, 20222 United States
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Study Endpoints
Primary Endpoints
Number of serious adverse events (SAE)
Approximately 30 days
Number of deaths
Approximately 30 days
Number of adverse events (AE) leading to study discontinuation
Approximately 30 days
Number of patients with clinically significant changes in ECG parameters, as defined by the investigator
Approximately 30 days
Number of patients with potentially clinically significant changes in vital signs
Approximately 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ascending dose (SAD): BMS-986235 or PlaceboEXPERIMENTALBMS-986235 or Placebo oral dose
Multiple ascending dose (MAD): BMS-986235 or PlaceboEXPERIMENTALBMS-986235 or Placebo oral dose
Interventions
NameTypeDescription
BMS-986235DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations * Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive Exclu...

Countries:United States
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