[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629010":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Shanghai Synvida Biotechnology Co.,Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SV003","EXPERIMENTAL",null,[13],"Drug: SV003",{"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","SV003：Single-dose",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo ： Single-dose",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Qian Chen","CONTACT","86-021-36682212","xhzxyy@xh.sh.cn",[34],{"facility":35,"status":36,"city":37,"state":11,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Shanghai Xuhui Central Hospital","RECRUITING","Shanghai","200237","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100629010","phase-1-a-clinical-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-sv003-in-healthy-participants-100629010",false,"NCT07469085","A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.","A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.","Inclusion Criteria:\n\n1. Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg\u002Fm², 18.5 ≤ Caucasian participants ≤ 32 kg\u002Fm²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;\n2. Healthy status: No evidence of active or chronic diseases in participants;\n3. Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.\n\nExclusion Criteria:\n\n1. Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;\n2. Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;\n3. Subjects with designated examination results reaching a specified value;\n4. Subjects with abnormal laboratory test results deemed clinically significant by the investigator;\n5. Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;\n6. Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;\n7. Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;\n8. Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;\n9. Subjects who have donated blood or lost blood ≥ 400 mL within 3 months prior to drug administration, or donated blood or lost blood ≥ 200 mL within 1 month, or with a history of blood product use;\n10. Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;\n11. Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;\n12. Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;\n13. Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;\n14. Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, who refuse to adopt reliable contraceptive measures during the study and for 6 months after the last drug administration;\n15. Any other factors that the investigator deems may render a subject unsuitable for study participation.",true,"ALL","18 Years","45 Years",{"count":63,"type":64},60,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.",[70],"Healthy Participants","2026-04-07",{"date":73,"type":74},"2026-04-08","ACTUAL",{"date":76,"type":74},"2026-04-04",{"date":78,"type":64},"2027-03-31",{"name":5,"class":6},1]