Actively Recruiting
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-19
200
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form before starting the trial activities
- Have a Numerical Evaluation Scale (NRS) pain score of 4 or higher in the affected knee at screening
- Willing to stop all other osteoarthritis pain treatments except for rescue acetaminophen and avoid prohibited analgesics during the study
- Agree to use highly effective contraception from consent signing until 1 month after the last dose if of childbearing potential
You will not qualify if you...
- History of other diseases affecting the target joint
- History of major trauma or surgery to the knee or hip joint within the past year
- Planning to undergo surgery during the study
- Most or complete loss of mobility
- Presence of other diseases that could confuse osteoarthritis pain assessment
- Neuropsychiatric disease affecting osteoarthritis evaluation or self-scoring
- Serious or poorly controlled concomitant diseases
- History of peptic ulcer, bleeding, perforation, or obstruction within 1 year before screening
- Need for drug treatment or surgical intervention
- History of malignant tumors within 5 years before screening
- History of drug abuse or alcoholism within 2 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Drum Tower Hospital affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210005
Actively Recruiting
Research Team
Z
Zhuang Nie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here