A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthr… (NCT07351968) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
China200 participantsStarted 2026-03-10
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
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