RecruitingPhase 1NCT07351968

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


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

200 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1b study is testing a new investigational drug called HRS-2129 at different doses to see how well it relieves moderate to severe knee pain caused by osteoarthritis, and to assess its safety and how the body processes it. Knee osteoarthritis is a degenerative joint condition causing cartilage breakdown, pain, and reduced mobility. Adults with knee osteoarthritis whose pain scores 4 or more out of 10, who are willing to stop other pain medications (except acetaminophen) during the study, and who do not have a recent history of knee surgery, severe health conditions, or malignancy are eligible. Participation involves receiving HRS-2129 injections or infusions at different dose levels, with clinic visits for pain assessments, blood samples for drug level monitoring, and safety evaluations. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-2129 Tablet

HRS-2129 tablet.

DRUGCelecoxib capsule

Celecoxib capsule.

DRUGCelecoxib Capsule Placebo

Celecoxib capsule placebo.

DRUGHRS-2129 Tablet Placebo

HRS-2129 tablet placebo.


Locations(1)

Drum Tower Hospital affiliated to Nanjing University School of Medicine

Nanjing, Jiangsu, China

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NCT07351968