[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629010":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":36,"interventions":47,"overallOfficials":26,"centralContacts":55,"locations":61,"responsibleParty":77,"collaborators":26,"id":79,"slug":26,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":26,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"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 3 months",[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","SEQUENTIAL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","INVESTIGATOR",[37,42],{"label":38,"type":39,"description":26,"interventionNames":40},"SV003","EXPERIMENTAL",[41],"Drug: SV003",{"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","SV003：Single-dose",[38],{"type":49,"name":43,"description":53,"armGroupLabels":54,"otherNames":26},"Placebo ： Single-dose",[43],[56],{"name":57,"role":58,"phone":59,"phoneExt":26,"email":60},"Qian Chen","CONTACT","86-021-36682212","xhzxyy@xh.sh.cn",[62],{"facility":63,"status":64,"city":65,"state":26,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Shanghai Xuhui Central Hospital","RECRUITING","Shanghai","200237","China","CN",{"type":70,"coordinates":71},"Point",[72,73],121.45806,31.22222,{"lat":73,"lon":72},[76],{"name":57,"role":58,"phone":59,"phoneExt":26,"email":60},{"type":78,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.",[97],"Healthy Participants","2026-04-07",{"date":100,"type":101},"2026-04-08","ACTUAL",{"date":103,"type":101},"2026-04-04",{"date":105,"type":91},"2027-03-31",{"name":5,"class":6},1]