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BMS-986326

Phase 1

Healthy Participants | Monoclonal antibody | Other |Bristol-Myers Squibb Company|Last Updated: May 6, 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 Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04736134A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy ParticipantsPHASE1 COMPLETED 88Mar 3, 2021Mar 14, 2024May 6, 20241 Germany
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
Up to 175 days
Number of participants with clinical laboratory abnormalities
Up to 175 days
Number of participants with vital sign abnormalities
Up to 175 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 175 days
Number of participants with physical examinations abnormalities
Up to 175 days
Secondary Endpoints
Maximum observed serum concentration (Cmax)
Up to 175 days
Time of maximum observed serum concentration (Tmax)
Up to 175 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Up to 175 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active Treatment (BMS 986326) IVEXPERIMENTALIntravenous (IV)
Active Treatment (BMS 986326) SCEXPERIMENTALSubcutaneous (SC)
Placebo IVPLACEBO_COMPARATOR -
Placebo SCPLACEBO_COMPARATOR -
Multiple Ascending Dose Placebo SCPLACEBO_COMPARATORPlacebo
Multiple Ascending Dose SCEXPERIMENTALBMS 986326 SC
Interventions
NameTypeDescription
BMS-986326BIOLOGICALSpecified dose on specified days
Placebo matching BMS-986326OTHERSpecified dose on specified days
Multiple Ascending Dose SCBIOLOGICALSpecified dose on specified days
Multiple Ascending Dose PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health, as determined by the investigator based on a physical examination at screening * Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening * Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and hea...

Countries:Germany
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