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BMS-986325

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Nov 7, 2023

BMS-986325 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

BMS-986325 clinical trials

BMS-986325 · 1 trial · 1 indication

Phase 1 1
NCT05813717A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese ParticipantsHealthy Volunteers
COMPLETED25 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about BMS-986325

What is BMS-986325?

BMS-986325 is an investigational small molecule drug being developed by Bristol-Myers Squibb Company. It is in Phase 1 clinical development, and the specific diseases or conditions it is intended to treat have not been disclosed. It has been studied in healthy volunteers rather than in patients with a named disease.

Who makes BMS-986325?

BMS-986325 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the compound conducted in the United States.

What phase is BMS-986325 in?

BMS-986325 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.

What clinical trials is BMS-986325 in?

BMS-986325 has been evaluated in one completed Phase 1 trial, NCT05813717, titled A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants. The trial enrolled 25 healthy volunteers in the United States and used a randomized, double-blind, controlled design.

What was studied in the BMS-986325 Phase 1 trial?

The Phase 1 trial NCT05813717 evaluated the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy Japanese participants. It enrolled 25 healthy volunteers aged 18 years and older in the United States and was randomized, double-blind, and controlled. The study has been completed.