Painful Osteoarthritis of the Knee Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Doses of MEDI7352 Administered by the Subcutaneous Route in Healthy Japanese and Caucasian Subjects
This study will evaluate safety, tolerability, pharmacokinetics and immunogenicity of MEDI7352 in healthy participants.
The study will comprise: - A Screening Period of up to 36 days (approximately 5 weeks); - A Treatment Period of 6 weeks where participants will be given 1 dose of study treatment every 2 weeks (4 doses in total). Participants will be required to stay in the Clinical Unit from Days -1 to 8 (Visit 2), from Days 14 to 15 (Visit 6), from Days 28 to 29 (Visit 9), and from Days 42 to 50 (Visit 12). In addition, participants will have multiple visits to the Clinical Unit to complete the study assessments; - A Follow-up Period of 42 days (6 weeks) where participants will also have multiple visits to the Clinical Unit to complete the study assessments, and; - A final Follow-up Visit after 42 days after the Treatment Period. Participants will receive fixed multiple subcutaneous (SC) doses of MEDI7352 or placebo on 4 occasions; one dose every 2 weeks on Days 1, 15, 29 and 43, under fasted conditions. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02688543 -
Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.
|
N/A | |
| Completed |
NCT04675034 -
A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee
|
Phase 2 |