[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620003":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":50,"locations":56,"responsibleParty":78,"collaborators":37,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":37,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":37,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":37,"overallStatus":59,"whyStopped":37,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",[8,16,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-2129 High Dose Group","EXPERIMENTAL","HRS-2129 high dose group.",[13,14,15],"Drug: HRS-2129 Tablet","Drug: Celecoxib Capsule Placebo","Drug: HRS-2129 Tablet Placebo",{"label":17,"type":10,"description":18,"interventionNames":19},"HRS-2129 Low Dose Group","HRS-2129 low dose group.",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"Celecoxib Group","ACTIVE_COMPARATOR","Celecoxib group.",[25,15],"Drug: Celecoxib capsule",{"label":27,"type":28,"description":29,"interventionNames":30},"Placebo Group","PLACEBO_COMPARATOR","Placebo group.",[14,15],[32,38,42,46],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","HRS-2129 Tablet","HRS-2129 tablet.",[9,17],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Celecoxib capsule","Celecoxib capsule.",[21],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Celecoxib Capsule Placebo","Celecoxib capsule placebo.",[9,17,27],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"HRS-2129 Tablet Placebo","HRS-2129 tablet placebo.",[21,9,17,27],[51],{"name":52,"role":53,"phone":54,"phoneExt":37,"email":55},"Zhuang Nie","CONTACT","+86-0518-82342973","zhuang.nie@hengrui.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Drum Tower Hospital affiliated to Nanjing University School of Medicine","RECRUITING","Nanjing","Jiangsu","210005","China","CN",{"type":66,"coordinates":67},"Point",[68,69],118.77778,32.06167,{"lat":69,"lon":68},[72,76],{"name":73,"role":53,"phone":74,"phoneExt":37,"email":75},"Qing Jiang","+86-025-83106666","jiangqing112@hotmail.com",{"name":73,"role":77,"phone":37,"phoneExt":37,"email":37},"PRINCIPAL_INVESTIGATOR",{"type":79,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":91,"type":92},200,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98,99],"Moderate Pain in Knee Osteoarthritis","Severe Pain in Knee Osteoarthritis","2026-03-18",{"date":102,"type":103},"2026-03-19","ACTUAL",{"date":105,"type":103},"2026-03-10",{"date":107,"type":92},"2026-08",{"name":5,"class":6},1]