Clinical Trial Details

Trial ID: L0605
Source ID: NCT02538874
Associated Drug: BMS-986171
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
Acronym: --
Status: Not recruiting
Study Results: No Results Available
Results: --
Conditions: Liver Fibrosis/NASH;Liver Fibrosis/NASH;Liver Fibrosis/NASH;Liver Fibrosis/NASH
Interventions: Drug: BMS-986171;Other: Placebo;Drug: BMS-986171;Other: Placebo;Drug: BMS-986171;Other: Placebo;Drug: BMS-986171;Other: Placebo
Outcome Measures: 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;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;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;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;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;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;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;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;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;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;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;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 examinationsImmunogenicity based on antibody responses
Sponsor/Collaborators: Bristol-Myers Squibb
Gender: All
Age: 21 Years55 Years
Phases: Phase 1
Enrollment: 275
Study Type: Interventional
Study Designs: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
Start Date: 21/08/2015
Completion Date: --
Results First Posted: --
Last Update Posted: 16 December 2017
Locations: United States;United States;United States;United States;United States
URL: https://clinicaltrials.gov/show/NCT02538874