[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602277":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":163,"collaborators":11,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":11,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":11,"enrollmentInfo":174,"targetDuration":11,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Shanghai Synvida Biotechnology Co.,Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SV001","EXPERIMENTAL",null,[13],"Drug: SV001",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","SV001 ： Multiple-dose",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo ： Multiple-dose",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Jinfu Xu","CONTACT","86-21-62483180","hdyyll@126.com",[34,49,60,71,82,93,104,115,122,130,141,152],{"facility":35,"status":36,"city":37,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Sichuan Provincial People's Hospital","RECRUITING","Chengdu","China","CN",{"type":41,"coordinates":42},"Point",[43,44],104.06667,30.66667,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":11,"phoneExt":11,"email":11},"Lu Guo",{"facility":50,"status":36,"city":51,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"The First Affiliated Hospital of Guangzhou Medical University","Guangzhou",{"type":41,"coordinates":53},[54,55],113.25,23.11667,{"lat":55,"lon":54},[58],{"name":59,"role":30,"phone":11,"phoneExt":11,"email":11},"Qun Luo",{"facility":61,"status":36,"city":62,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Hangzhou First People's Hospital","Hangzhou",{"type":41,"coordinates":64},[65,66],120.16142,30.29365,{"lat":66,"lon":65},[69],{"name":70,"role":30,"phone":11,"phoneExt":11,"email":11},"Limin Wang",{"facility":72,"status":36,"city":73,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"The First Affiliated Hospital of Nanchang University","Nanchang",{"type":41,"coordinates":75},[76,77],115.85306,28.68396,{"lat":77,"lon":76},[80],{"name":81,"role":30,"phone":11,"phoneExt":11,"email":11},"Xuan Wan",{"facility":83,"status":36,"city":84,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School","Nanjing",{"type":41,"coordinates":86},[87,88],118.77778,32.06167,{"lat":88,"lon":87},[91],{"name":92,"role":30,"phone":11,"phoneExt":11,"email":11},"Min Cao",{"facility":94,"status":36,"city":95,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"The Affiliated Hospital of Inner Mongolia Medical University","Neimeng",{"type":41,"coordinates":97},[98,99],119.33442,28.53675,{"lat":99,"lon":98},[102],{"name":103,"role":30,"phone":11,"phoneExt":11,"email":11},"Junzhen Gao",{"facility":105,"status":36,"city":106,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Dongfang Hospital Affiliated to Tongji University","Shanghai",{"type":41,"coordinates":108},[109,110],121.45806,31.22222,{"lat":110,"lon":109},[113],{"name":114,"role":30,"phone":11,"phoneExt":11,"email":11},"Qiang Li",{"facility":116,"status":36,"city":106,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":117,"geoPoint":119,"contacts":120},"Huadong Hospital Affiliated to Fudan University",{"type":41,"coordinates":118},[109,110],{"lat":110,"lon":109},[121],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"facility":123,"status":36,"city":106,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Shanghai Pulmonary Hospital",{"type":41,"coordinates":125},[109,110],{"lat":110,"lon":109},[128],{"name":129,"role":30,"phone":11,"phoneExt":11,"email":11},"Qiuhong Li",{"facility":131,"status":36,"city":132,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"General Hospital of Tianjin Medical University","Tianjin",{"type":41,"coordinates":134},[135,136],117.17667,39.14222,{"lat":136,"lon":135},[139],{"name":140,"role":30,"phone":11,"phoneExt":11,"email":11},"Jie Cao",{"facility":142,"status":36,"city":143,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"The Affiliated Hospital of Xuzhou Medical University","Xuzhou",{"type":41,"coordinates":145},[146,147],117.28386,34.20442,{"lat":147,"lon":146},[150],{"name":151,"role":30,"phone":11,"phoneExt":11,"email":11},"Bi Chen",{"facility":153,"status":36,"city":154,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Henan Provincial People's Hospital","Zhengzhou",{"type":41,"coordinates":156},[157,158],113.64861,34.75778,{"lat":158,"lon":157},[161],{"name":162,"role":30,"phone":11,"phoneExt":11,"email":11},"Xiaoju Zhang",{"type":164,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602277","phase-2-a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-sv001-in-patients-with-idiopathic-pulmonary-fibrosis-100602277",false,"NCT07121413","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis","A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;\n2. Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;\n3. Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.\n\nExclusion Criteria:\n\n1. Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;\n2. Presence of any other clinically significant pulmonary diseases besides IPF at screening;\n3. Any known contraindications to performing pulmonary function tests at screening;\n4. Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;\n5. Acute exacerbation of IPF within 4 months prior to randomization;\n6. Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening;\n7. History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period;\n8. Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;\n9. Presence of specified abnormal laboratory test results at screening;\n10. Evidence of renal impairment or end-stage renal disease requiring dialysis at screening;\n11. Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease;\n12. History of malignancy within 5 years prior to screening;\n13. Difficulty with venipuncture or a history of needle phobia or blood phobia;\n14. Positive pregnancy tests or currently lactating at screening;\n15. Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;\n16. Any other condition that the investigator consider unsuitable for participation in the study.","ALL","40 Years",{"count":175,"type":176},48,"ESTIMATED","INTERVENTIONAL",[179],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.",[182],"Idiopathic Pulmonary Fibrosis(IPF)","2026-02-08",{"date":185,"type":186},"2026-02-11","ACTUAL",{"date":188,"type":186},"2025-11-04",{"date":190,"type":176},"2026-12-31",{"name":5,"class":6},12]