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Report for Clinical Trial NCT02318407

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Younger and Older Subjects With Osteoarthritis Knee Pain

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).

NCT02318407 Osteoarthritis
MeSH:Osteoarthritis Osteoarthritis, Knee
HPO:Knee osteoarthritis Osteoarthritis

2 Interventions

Name: AMG 403

Description: AMG 403 for the treatment of subjects with osteoarthritis
Type: Drug
Group Labels: 1

AMG 403

Name: Placebo

Description: contains no active drug
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q28D

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 ---



HPO Nodes


HPO: