[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641587":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":32,"locations":38,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},{"fullName":5,"class":6},"Zai Lab (Hong Kong), Ltd.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"ZL-1503 (Intravenous Administration)","EXPERIMENTAL",null,[13],"Drug: ZL-1503",{"label":15,"type":10,"description":11,"interventionNames":16},"ZL-1503 (Subcutaneous Dose 1)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"ZL-1503 (Subcutaneous Dose2)",[13],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","ZL-1503","Healthy volunteers will receive a single intravenous dose of ZL-1503.",[9],{"type":22,"name":23,"description":27,"armGroupLabels":28,"otherNames":11},"Healthy volunteers will receive a single subcutaneous administration at Dose 1.",[15],{"type":22,"name":23,"description":30,"armGroupLabels":31,"otherNames":11},"Healthy volunteers will receive a single subcutaneous administration at Dose 2.",[18],[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"ZaiLab Medical Director","CONTACT","+86 021-61632588","ZL-1503-002_StudyTeam@zailaboratory.com",[39],{"facility":40,"status":11,"city":41,"state":41,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"ZaiLab Site 18001","Auckland","New Zealand","NZ",{"type":45,"coordinates":46},"Point",[47,48],174.76349,-36.84853,{"lat":48,"lon":47},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100641587","phase-1-a-phase-1-study-to-evaluate-pharmacokinetics-safety-and-tolerability-of-zl-1503-in-healthy-volunteers-100641587",false,"NCT07658482","A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers","A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-1503 Following a Single Dose of Subcutaneous or Intravenous Administration in Healthy Volunteers.","Inclusion Criteria:\n\n* Healthy male and female volunteers, 18-65 years of age\n* Body mass index (BMI) between ≥ 18.5 and \\\u003C 32.5 kg\u002Fm2\n* Negative pregnancy tests for women of childbearing potential.\n\nExclusion Criteria:\n\n* Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.\n* History of major metabolic, liver, kidney, hematologic or other significant disorders.\n* Abnormal Electrocardiogram (ECG) findings\n* Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function.\n* History of drug abuse or addiction within 6 months prior to screening\n* Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.\n* Donated \\>500mL blood within 2 months of dosing.",true,"ALL","18 Years","65 Years",{"count":64,"type":65},36,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This is a phase 1, single dose, randomized, open-label, parallel-group study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of ZL-1503 and to explore its PD biomarkers following a single subcutaneous (SC) or intravenous (IV) administration in healthy volunteers.",[71],"Healthy Volunteers",[73],"Healthy volunteers","NOT_YET_RECRUITING","2026-06-18",{"date":77,"type":78},"2026-06-22","ACTUAL",{"date":80,"type":65},"2026-09-03",{"date":82,"type":65},"2027-11-10",{"name":84,"class":6},"Zai Lab (Shanghai) Co., Ltd.",1]