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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Liver Fibrosis/NASH

Treatments: Drug: BMS-986171; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02538874

MB007-005

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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275 participants in 3 patient groups

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

BMS-986171 or Placebo on specified days

Treatment:

Drug: BMS-986171

Other: Placebo

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

BMS-986171 or Placebo on specified days

Treatment:

Drug: BMS-986171

Other: Placebo

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

Experimental group

Description:

BMS-986171 or Placebo on specified days

Treatment:

Drug: BMS-986171

Other: Placebo