NCT07351968

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate Pain in Knee Osteoarthritis
• Severe Pain in Knee Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-01-20
• Last updated: 2026-03-19

Locations

1 site across 1 country: China