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BMS-986171

Phase 1

Liver Fibrosis/NASH | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: May 24, 2017

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment275
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02538874A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the BodyPHASE1 COMPLETED 275 — — Oct 31, 2015Nov 5, 2016May 24, 20172 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
up to 30 days after the last dose

Adverse Event (AE)

Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
up to 30 days after the last dose
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
up to 30 days after the last dose
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
up to 30 days after the last dose
Secondary Endpoints
Immunogenicity based on antibody responses
6 months following study discharge.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A: Single Ascending Dose (SAD)EXPERIMENTALBMS-986171 or Placebo on specified days
Part B: Multiple Ascending Dose (MAD)EXPERIMENTALBMS-986171 or Placebo on specified days
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)EXPERIMENTALBMS-986171 or Placebo on specified days
Interventions
NameTypeDescription
BMS-986171DRUG -
PlaceboOTHER -
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Age 21 to 55 years (Part A,B, and C) * BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ \[height (m)\] Exclusion Criteria: * Any significant medical ill...

Countries:United States
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