[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602277":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":36,"interventions":47,"overallOfficials":26,"centralContacts":55,"locations":61,"responsibleParty":191,"collaborators":26,"id":193,"slug":26,"hasResults":194,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":26,"eligibilityCriteria":198,"healthyVolunteers":194,"sex":199,"minAge":200,"maxAge":26,"enrollmentInfo":201,"targetDuration":26,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":26,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Shanghai Synvida Biotechnology Co.,Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","Adverse event type, incidence, duration","Approximately 1 years",[14,17,19,21,23],{"measure":15,"description":16,"timeFrame":12},"Peak Plasma Concentration (Cmax)","PK (Pharmacokinetics)",{"measure":18,"description":16,"timeFrame":12},"Peak time（Tmax）",{"measure":20,"description":16,"timeFrame":12},"Area under the plasma concentration versus time curve (AUC)",{"measure":22,"description":16,"timeFrame":12},"half-life（T1\u002F2）",{"measure":24,"description":25,"timeFrame":12},"Immunogenicity","ADA（Anti-drug antibody）",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","INVESTIGATOR",[37,42],{"label":38,"type":39,"description":26,"interventionNames":40},"SV001","EXPERIMENTAL",[41],"Drug: SV001",{"label":43,"type":44,"description":26,"interventionNames":45},"Placebo","PLACEBO_COMPARATOR",[46],"Drug: Placebo",[48,52],{"type":49,"name":38,"description":50,"armGroupLabels":51,"otherNames":26},"DRUG","SV001 ： Multiple-dose",[38],{"type":49,"name":43,"description":53,"armGroupLabels":54,"otherNames":26},"Placebo ： Multiple-dose",[43],[56],{"name":57,"role":58,"phone":59,"phoneExt":26,"email":60},"Jinfu Xu","CONTACT","86-21-62483180","hdyyll@126.com",[62,77,88,99,110,121,132,143,150,158,169,180],{"facility":63,"status":64,"city":65,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Sichuan Provincial People's Hospital","RECRUITING","Chengdu","China","CN",{"type":69,"coordinates":70},"Point",[71,72],104.06667,30.66667,{"lat":72,"lon":71},[75],{"name":76,"role":58,"phone":26,"phoneExt":26,"email":26},"Lu Guo",{"facility":78,"status":64,"city":79,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"The First Affiliated Hospital of Guangzhou Medical University","Guangzhou",{"type":69,"coordinates":81},[82,83],113.25,23.11667,{"lat":83,"lon":82},[86],{"name":87,"role":58,"phone":26,"phoneExt":26,"email":26},"Qun Luo",{"facility":89,"status":64,"city":90,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Hangzhou First People's Hospital","Hangzhou",{"type":69,"coordinates":92},[93,94],120.16142,30.29365,{"lat":94,"lon":93},[97],{"name":98,"role":58,"phone":26,"phoneExt":26,"email":26},"Limin Wang",{"facility":100,"status":64,"city":101,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"The First Affiliated Hospital of Nanchang University","Nanchang",{"type":69,"coordinates":103},[104,105],115.85306,28.68396,{"lat":105,"lon":104},[108],{"name":109,"role":58,"phone":26,"phoneExt":26,"email":26},"Xuan Wan",{"facility":111,"status":64,"city":112,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School","Nanjing",{"type":69,"coordinates":114},[115,116],118.77778,32.06167,{"lat":116,"lon":115},[119],{"name":120,"role":58,"phone":26,"phoneExt":26,"email":26},"Min Cao",{"facility":122,"status":64,"city":123,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"The Affiliated Hospital of Inner Mongolia Medical University","Neimeng",{"type":69,"coordinates":125},[126,127],119.33442,28.53675,{"lat":127,"lon":126},[130],{"name":131,"role":58,"phone":26,"phoneExt":26,"email":26},"Junzhen Gao",{"facility":133,"status":64,"city":134,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Dongfang Hospital Affiliated to Tongji University","Shanghai",{"type":69,"coordinates":136},[137,138],121.45806,31.22222,{"lat":138,"lon":137},[141],{"name":142,"role":58,"phone":26,"phoneExt":26,"email":26},"Qiang Li",{"facility":144,"status":64,"city":134,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Huadong Hospital Affiliated to Fudan University",{"type":69,"coordinates":146},[137,138],{"lat":138,"lon":137},[149],{"name":57,"role":58,"phone":59,"phoneExt":26,"email":60},{"facility":151,"status":64,"city":134,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Shanghai Pulmonary Hospital",{"type":69,"coordinates":153},[137,138],{"lat":138,"lon":137},[156],{"name":157,"role":58,"phone":26,"phoneExt":26,"email":26},"Qiuhong Li",{"facility":159,"status":64,"city":160,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"General Hospital of Tianjin Medical University","Tianjin",{"type":69,"coordinates":162},[163,164],117.17667,39.14222,{"lat":164,"lon":163},[167],{"name":168,"role":58,"phone":26,"phoneExt":26,"email":26},"Jie Cao",{"facility":170,"status":64,"city":171,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"The Affiliated Hospital of Xuzhou Medical University","Xuzhou",{"type":69,"coordinates":173},[174,175],117.28386,34.20442,{"lat":175,"lon":174},[178],{"name":179,"role":58,"phone":26,"phoneExt":26,"email":26},"Bi Chen",{"facility":181,"status":64,"city":182,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Henan Provincial People's Hospital","Zhengzhou",{"type":69,"coordinates":184},[185,186],113.64861,34.75778,{"lat":186,"lon":185},[189],{"name":190,"role":58,"phone":26,"phoneExt":26,"email":26},"Xiaoju Zhang",{"type":192,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":202,"type":203},48,"ESTIMATED","INTERVENTIONAL",[206],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.",[209],"Idiopathic Pulmonary Fibrosis(IPF)","2026-02-08",{"date":212,"type":213},"2026-02-11","ACTUAL",{"date":215,"type":213},"2025-11-04",{"date":217,"type":203},"2026-12-31",{"name":5,"class":6},12]