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RECRUITING
NCT07351968
PHASE1

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-03-10

Completion Date

2026-08

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

HRS-2129 Tablet

HRS-2129 tablet.

DRUG

Celecoxib capsule

Celecoxib capsule.

DRUG

Celecoxib Capsule Placebo

Celecoxib capsule placebo.

DRUG

HRS-2129 Tablet Placebo

HRS-2129 tablet placebo.

Locations (1)

Drum Tower Hospital affiliated to Nanjing University School of Medicine

Nanjing, Jiangsu, China