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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain

NCT02318407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-12-17

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

AMG 403

AMG 403 for the treatment of subjects with osteoarthritis

DRUG

Placebo

contains no active drug

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-01-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318407 on ClinicalTrials.gov