> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-study-to-evaluate-the-efficacy-and-safety-of-hrs-fd661d6d-fc40-45fe-810e-9c23cc4f2bd4 > Record changed: 2026-10-13 # A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis NCT07351968 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) Participants 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) Lead sponsor Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) Start date 2026-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Short title** A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Dates **Completion date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **First posted** 2026-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Registry last updated** 2026-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Primary completion date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Start date** 2026-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Size and sites **Participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Planned participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Lead sponsor** Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Identifiers **Registry ID** NCT07351968 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **ClinicalTrials.gov ID** NCT07351968 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Outcomes ### Primary outcomes 1. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Timeframe: At week 4. ### Secondary outcomes 1. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Timeframe: From baseline to Week 1, 2 and 3. 2. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores. Timeframe: From baseline to Week 1, 2, 3 and 4. 3. Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting). Timeframe: From baseline to Week 1, 2, 3 and 4. 4. Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking). Timeframe: From baseline to Week 1, 2, 3 and 4. 5. Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale. Timeframe: From baseline to Week 1, 2, 3 and 4. 6. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores. Timeframe: From baseline to Week 1, 2, 3 and 4. 7. Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Timeframe: From baseline to Week 1, 2, 3 and 4. 8. Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline. Timeframe: At Week 1, 2, 3 and 4. 9. Adverse events (AEs) occurred during the study. Timeframe: During the study, approximately 8 months. To evaluate the safety and tolerability of HRS-2129 tablets. 10. Serious adverse events (SAEs) occurred during the study. Timeframe: During the study, approximately 8 months. To evaluate the safety and tolerability of HRS-2129 tablets. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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; 11. Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Sites - Drum Tower Hospital affiliated to Nanjing University School of MedicineNanjing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351968) ## Related records ### Drugs (2) - [Celecoxib](https://trialight.com/data/asset/celecoxib-d2adc66b-f8fb-471f-8779-d55e35cdd52c.md) - [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md) ### Lead sponsors (1) - [Shandong Suncadia Medicine Co., Ltd.](https://trialight.com/data/company/shandong-suncadia-medicine-co-ltd-c4ebee86-20f2-45b5-9857-30794a216c9a.md) ### Targets (1) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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