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).
Name: AMG 403
Description: AMG 403 for the treatment of subjects with osteoarthritisType: DrugAMG 403
Name: Placebo
Description: contains no active drugType: DrugPlacebo
Description: Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
Measure: 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 Time: from 197 days to 211 daysDescription: serum concentrations and derived PK parameters of AMG 403
Measure: Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax Time: from 197 days to 211 daysAllocation: Randomized
Parallel Assignment
There is one SNP
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). --- Q28D ---