A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Moderate Pain in Knee Osteoarthritis, Severe Pain in Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT07351968

Run by

Shandong Suncadia Medicine Co., Ltd.

People needed

200

Starts

2026-03-10

Expected to finish

2026-08-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History of other diseases that may involve the target joint;
• History of major trauma or surgery of knee joint and hip joint in the past year;
• Plan to undergo surgical procedure during the study;
• Most or complete loss of mobility;
• There are other diseases that may confuse the assessment of osteoarthritis pain;
• There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
• There are serious or poorly controlled concomitant diseases;
• Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
• Those who require drug treatment or surgical intervention;
• History of malignant tumors within 5 years before screening;
• Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.

Where it is running

• Drum Tower Hospital affiliated to Nanjing University School of Medicine — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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