[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536619":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":38,"interventions":49,"overallOfficials":26,"centralContacts":26,"locations":57,"responsibleParty":76,"collaborators":26,"id":78,"slug":26,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"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},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,44],{"label":40,"type":41,"description":26,"interventionNames":42},"SV001","EXPERIMENTAL",[43],"Drug: SV001",{"label":45,"type":46,"description":26,"interventionNames":47},"Placebo","PLACEBO_COMPARATOR",[48],"Drug: Placebo",[50,54],{"type":51,"name":40,"description":52,"armGroupLabels":53,"otherNames":26},"DRUG","SV001 ： single-dose",[40],{"type":51,"name":45,"description":55,"armGroupLabels":56,"otherNames":26},"Placebo ： single-dose",[45],[58],{"facility":59,"status":60,"city":61,"state":26,"zip":26,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Shanghai Xuhui District Central Hospital","RECRUITING","Shanghai","China","CN",{"type":65,"coordinates":66},"Point",[67,68],121.45806,31.22222,{"lat":68,"lon":67},[71],{"name":72,"role":73,"phone":74,"phoneExt":26,"email":75},"Qian Chen","CONTACT","0086-021-54036058","qchen@shxh-centerlab.com",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100536619",false,"NCT06267183","A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.","A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.","Inclusion Criteria:\n\n1. Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;\n2. Subjects must have a Body Mass Index in the range of 19\\~26 kg\u002Fm2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;\n3. Subjects must be in good health as judged by the investigator.\n4. Reliable contraception must be assured during and for some time after the trial.\n\nExclusion Criteria:\n\n1. Subjects with a history of drug or other substance anaphylaxis;\n2. Subjects with respiratory symptoms or abnormal respiratory tract;\n3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;\n4. Subjects with other diseases or factors with abnormal clinical manifestations;\n5. Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;\n6. Subjects who smoked more than 5 cigarettes a day in the period before screening;\n7. Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;\n8. Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;\n9. Subjects who used other drugs within a certain period of time before receiving the investigational drug;\n10. Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;\n11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.\n12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;\n13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;\n14. Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;\n15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;\n16. Any other status in which the investigator deems inappropriate to participate in the present study.","ALL","18 Years","45 Years",{"count":88,"type":89},53,"ESTIMATED","INTERVENTIONAL",[92],"EARLY_PHASE1","The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.",[95],"Idiopathic Pulmonary Fibrosis","2026-03-09",{"date":98,"type":99},"2026-03-11","ACTUAL",{"date":101,"type":99},"2024-01-12",{"date":103,"type":89},"2026-12-30",{"name":5,"class":6},1]