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A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT07351968•Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent form before starting the activities related to the trial;
•2. The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
•3. 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 ;
•4. 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

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

Locations (1)

Drum Tower Hospital affiliated to Nanjing University School of Medicine

Nanjing, Jiangsu, China

Key Dates

Start Date

March 10, 2026

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

March 19, 2026

Enrollment

200

ESTIMATED participants

Conditions

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

Interventions

HRS-2129 Tablet

DRUG

Celecoxib capsule

DRUG

Celecoxib Capsule Placebo

DRUG

HRS-2129 Tablet Placebo

DRUG

Contacts

Zhuang Nie

CONTACT

+86-0518-82342973 zhuang.nie@hengrui.com