A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
- 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.
- Short title
- A Phase Ib Study to Evaluate the Efficacy and Safety 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-08-01
- First posted
- 2026-01-20
- Registry last updated
- 2026-03-19
- Primary completion date
- 2026-08-01
- Start date
- 2026-03-10
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07351968
- ClinicalTrials.gov ID
- NCT07351968
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Timeframe: At week 4.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Timeframe: From baseline to Week 1, 2 and 3.
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.
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.
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.
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.
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.
Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Timeframe: From baseline to Week 1, 2, 3 and 4.
Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.
Timeframe: At Week 1, 2, 3 and 4.
Adverse events (AEs) occurred during the study.
Timeframe: During the study, approximately 8 months.
To evaluate the safety and tolerability of HRS-2129 tablets.
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- Voluntarily sign the informed consent form before starting the activities related to the trial;
- The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
- 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 ;
- 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.
- History of other diseases that may involve the target joint;
- History of major trauma or surgery of knee joint and hip joint in the past year;
- Plan to undergo surgical procedure during the study;
- Most or complete loss of mobility;
- There are other diseases that may confuse the assessment of osteoarthritis pain;
- There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
- There are serious or poorly controlled concomitant diseases;
- Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
- Those who require drug treatment or surgical intervention;
- History of malignant tumors within 5 years before screening;
- Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.
- Drum Tower Hospital affiliated to Nanjing University School of MedicineNanjing, ChinaRecruiting