[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536619":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"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 ： single-dose",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo ： single-dose",[15],[28],{"facility":29,"status":30,"city":31,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Shanghai Xuhui District Central Hospital","RECRUITING","Shanghai","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Qian Chen","CONTACT","0086-021-54036058","qchen@shxh-centerlab.com",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100536619","early-phase-1-a-clinical-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-sv001-in-chinese-healthy-adult-volunteers-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":59,"type":60},53,"ESTIMATED","INTERVENTIONAL",[63],"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.",[66],"Idiopathic Pulmonary Fibrosis","2026-03-09",{"date":69,"type":70},"2026-03-11","ACTUAL",{"date":72,"type":70},"2024-01-12",{"date":74,"type":60},"2026-12-30",{"name":5,"class":6},1]