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

NCT02538874 | Completed Phase 1 FDA Drug

• 1 other identifier: MB007-005
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Fibrosis/NASH

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Immunogenicity based on antibody responses

  6 months following study discharge.

Study Arms (3)

Part A: Single Ascending Dose (SAD)

EXPERIMENTAL

BMS-986171 or Placebo on specified days

Drug: BMS-986171; Other: Placebo

Part B: Multiple Ascending Dose (MAD)

EXPERIMENTAL

BMS-986171 or Placebo on specified days

Drug: BMS-986171; Other: Placebo

Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)

EXPERIMENTAL

BMS-986171 or Placebo on specified days

Drug: BMS-986171; Other: Placebo

Interventions

BMS-986171 DRUG

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD); Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)

Placebo OTHER

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD); Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)/ \[height (m)\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Profil Institute For Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Wcct Global, Llc

Cypress, California, 90630, United States

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 2, 2015
• Study Start: October 31, 2015
• Primary Completion: November 4, 2016
• Study Completion: November 5, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

US (2)