Terminated/Withdrawn
Sponsor ID
20180224
Single and Multiple Ascending Dose Study of AMG 171 in Subjects with Obesity
Study Details
To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity
Protocol Summary
Primary Outcome Measures
Subject incidence of treatment-emergent adverse events.
Timeframe: through study completion, up to day 207
Subject incidence of clinically significant changes in laboratory safety test results
Timeframe: through study completion, up to day 207
Subject incidence of clinically significant changes in vital sign assessments
Timeframe: through study completion, up to day 207
Subject incidence of clinically significant changes in 12-lead electrocardiogram (ECG) assessments
Timeframe: through study completion, up to day 207
Secondary Outcome Measures
Pharmacokinetic parameter - maximum plasma concentration (Cmax)
Timeframe: through study completion, up to day 207
Pharmacokinetic parameter - time to maximum plasma concentration (Tmax)
Timeframe: through study completion, up to day 207
Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC)
Timeframe: through study completion, up to day 207
Incidence of anti-AMG 171 antibody formation
Timeframe: through study completion, up to day 207
Locations
Location
Orange County Research Center
Tustin, CA, United States, 92780
Status
Recruiting
Location
Anaheim Clinical Trials
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Clinical Pharmacology of Miami, LLC
Miami, FL, United States, 33014
Status
Recruiting