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

A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Liver Fibrosis/NASH
• Intervention / Treatment: Other: Placebo; Drug: BMS-986171

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Profil Institute for Clinical Research, Inc.
    • Cypress, California, United States, 90630
      • WCCT Global, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Single Ascending Dose (SAD); BMS-986171 or Placebo on specified days	Other: Placebo; Drug: BMS-986171
Experimental: Part B: Multiple Ascending Dose (MAD); BMS-986171 or Placebo on specified days	Other: Placebo; Drug: BMS-986171
Experimental: Part C: Multiple Ascending Dose in Japanese subjects (J-MAD); BMS-986171 or Placebo on specified days	Other: Placebo; Drug: BMS-986171

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Adverse Event (AE)	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 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

Outcome Measure	Time Frame
Immunogenicity based on antibody responses	6 months following study discharge.

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2015
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): November 5, 2016

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: MB007-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No