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A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Summary
Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.
Official title: A Multicenter, Randomized, Double-blind, Agent-positive and Placebo-controlled, Parallel-group Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03-10
Completion Date
2026-08
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
HRS-2129 Tablet
HRS-2129 tablet.
Celecoxib capsule
Celecoxib capsule.
Celecoxib Capsule Placebo
Celecoxib capsule placebo.
HRS-2129 Tablet Placebo
HRS-2129 tablet placebo.
Locations (1)
Drum Tower Hospital affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, China