A 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 Body

Phase 1

Completed

• Conditions: Liver Fibrosis/NASH
• Interventions: Drug: BMS-986171; Other: Placebo

• Registration Number: NCT02538874
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Study Start: 2015-10-31
• Primary Completion: 2016-11-04
• Study Completion: 2016-11-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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)]

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Exclusion Criteria

• Any significant medical illness
• Cannot tolerate subcutaneous injections, or having blood samples taken
• Smoking more than 10 cigarettes/day
• History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
• HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Single Ascending Dose (SAD)	BMS-986171	BMS-986171 or Placebo on specified days
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)	Placebo	BMS-986171 or Placebo on specified days
Part A: Single Ascending Dose (SAD)	Placebo	BMS-986171 or Placebo on specified days
Part B: Multiple Ascending Dose (MAD)	Placebo	BMS-986171 or Placebo on specified days
Part B: Multiple Ascending Dose (MAD)	BMS-986171	BMS-986171 or Placebo on specified days
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)	BMS-986171	BMS-986171 or Placebo on specified days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Immunogenicity based on antibody responses	6 months following study discharge.

Trial Locations

Locations (2)

Profil Institute For Clinical Research, Inc.; 🇺🇸 Chula Vista, California, United States

Wcct Global, Llc; 🇺🇸 Cypress, California, United States