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
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.
• Voluntarily sign the informed consent form before starting the activities related to the trial;
• The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
• Subjects must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ;
• Male and female subjects of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of investigational product.