[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-pain-in-knee-osteoarthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-pain-in-knee-osteoarthritis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100620003","phase-1-a-phase-ib-study-to-evaluate-the-efficacy-and-safety-of-hrs-2129-in-patients-with-knee-osteoarthritis-100620003",false,"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","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before starting the activities related to the trial;\n2. The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;\n3. 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 ;\n4. 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.\n\nExclusion Criteria:\n\n1. History of other diseases that may involve the target joint;\n2. History of major trauma or surgery of knee joint and hip joint in the past year;\n3. Plan to undergo surgical procedure during the study;\n4. Most or complete loss of mobility;\n5. There are other diseases that may confuse the assessment of osteoarthritis pain;\n6. There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;\n7. There are serious or poorly controlled concomitant diseases;\n8. Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;\n9. Those who require drug treatment or surgical intervention;\n10. History of malignant tumors within 5 years before screening;\n11. Have a history of drug abuse, drug abuse and\u002For alcoholism within 2 years before screening.","ALL","18 Years","80 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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.",[27,28],"Moderate Pain in Knee Osteoarthritis","Severe Pain in Knee Osteoarthritis","RECRUITING","2026-03-18",{"date":32,"type":33},"2026-03-19","ACTUAL",{"date":35,"type":33},"2026-03-10",{"date":37,"type":21},"2026-08",{"name":39,"class":40},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY"]