Study Complete
Sponsor ID
20060145
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects with Osteoarthritis Knee Pain
Study Details
This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4).
Protocol Summary
Primary Outcome Measures
Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
Timeframe: from 197 days to 211 days
Secondary Outcome Measures
Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
Timeframe: from 197 days to 211 days
Locations
No locations found.