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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 24
- Primary Endpoint
- 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
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with knee OA as determined by ACR criteria: Knee pain and radiographic osteophytes and at least 1 of the following 2 items: Morning stiffness 30 minutes, Crepitus on motion, a VAS pain score of ≥ 30 mm for index knee at screening,
Exclusion Criteria
- •Weight of > 125 kg, Inflammatory arthropathy including secondary OA (eg, degenerative arthritis in patients with rheumatoid arthritis) as confirmed by a rheumatologist or investigator, Diagnosis of a condition other than knee OA that, in the investigator's opinion, may cause or affect pain or pain assessment in the index knee; these conditions may include but are not limited to radiculopathy or neuropathy, vasculopathy, fibromyalgia or active depression, Subjects taking neuromodulatory agents (antiepileptics or antidepressants) used as analgesic therapy for neuropathic pain
Arms & Interventions
AMG 403
AMG 403 administered as subcutaneous doses
Intervention: AMG 403 (Drug)
Placebo
No active drug
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 Frame: from 197 days to 211 days
Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
Secondary Outcomes
- Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax(from 197 days to 211 days)