[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593553":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":18,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":18,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":18,"overallStatus":76,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SSS17","EXPERIMENTAL","The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort",[13,14],"Drug: SSS17 Capsule (6 Dose Levels)","Drug: Placebo Drug",{"label":16,"type":17,"description":18,"interventionNames":19},"placebo","PLACEBO_COMPARATOR",null,[13,14],[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":18},"DRUG","SSS17 Capsule (6 Dose Levels)","Arm1 ： This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly",[9,16],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":18},"Placebo Drug","Arm2：placebo The placebo intervention was matched with the six dose levels of SSS17, with each dose level assigning participants in a ratio of 4:1 (SSS17 to placebo).",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Professor Lin, Ph.D","CONTACT","010-88324516","rmyyllwyh@163.com",[37],{"facility":38,"status":18,"city":39,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Peking University People's Hospital","Beijing","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":18,"email":52},"Jianhao Lin Ph.D","135 0100 4301","jianhao_lin@hotmail.com",{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100593553","phase-2-phase-iia-trial-of-oral-sss17-for-post-arthroplasty-anemia-100593553",false,"NCT07007936","Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Oral SSS17 Capsules in the Treatment of Anemia Following Total Hip or Knee Arthroplasty","Inclusion Criteria:\n\n1. Signed informed consent obtained\n\n   \\-\n2. Age 18-70 years (inclusive)\n\n   \\-\n3. Candidates for hip\u002Fknee arthroplasty\n\n   \\-\n4. No DVT on pre-op venous ultrasound\n\n   \\-\n5. Screening Hb 80-110 g\u002FL (no transfusion indication) - 6. Commitment to effective contraception\n\nExclusion Criteria:\n\n1. Hypersensitivity to the investigational product or any of its components\n2. Any other condition causing chronic anemia\n3. Coagulopathy or unstable anticoagulant dosing during screening\n4. Any of the following laboratory abnormalities at screening:\n\n   1. Serum albumin \\\u003C35 g\u002FL\n   2. ALT or AST \\>3×ULN\n5. Active infections or carrier status including:\n\n   * Known HIV infection\n   * Active syphilis\n   * Active HBV infection (HBsAg-positive with HBV DNA \\>10³ copies\u002FmL)\n   * Active HCV infection (anti-HCV positive with detectable HCV RNA)\n6. Acute joint injury with active trauma or infection at screening\n7. Cognitive impairment or psychiatric disorders,current or history of epilepsy\n8. Treatment with ESAs (erythropoiesis-stimulating agents) or HIF inhibitors within 30 days prior to dosing\n9. History of severe thromboembolic events or hematopoietic disorders\n10. Malignancy history\n11. Severe cardiovascular diseases including:\n\n    * Unstable coronary artery disease\n    * Heart failure (NYHA Class III\u002FIV)\n    * Myocardial infarction\u002Fstroke 12 .Poorly controlled hypertension\n\n13\\. Alcohol abuse 14.Pregnancy or lactation 15.Participation in other drug trials within 3 months prior to enrollment 16.Any other condition deemed by the Investigator to compromise subject safety or trial validity","ALL","18 Years","70 Years",{"count":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","To assess the safety, tolerability, efficacy, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) characteristics of orally administered SSS17 capsules in patients with postoperative anemia following elective total hip or knee arthroplasty.",[73,74,75],"Postoperative Anemia","Arthroplasty, Replacement, Hip","Arthroplasty, Replacement, Knee","NOT_YET_RECRUITING","2025-06-06",{"date":79,"type":80},"2025-06-11","ACTUAL",{"date":82,"type":67},"2025-07",{"date":84,"type":67},"2026-04",{"name":5,"class":6},1]