Liver Fibrosis/NASH Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects
| Verified date | May 2017 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 275 |
| Est. completion date | November 5, 2016 |
| Est. primary completion date | November 4, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Profil Institute For Clinical Research, Inc. | Chula Vista | California |
| United States | Wcct Global, Llc | Cypress | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | Immunogenicity based on antibody responses | 6 months following study discharge. |