[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649091":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":48,"centralContacts":53,"locations":63,"responsibleParty":82,"collaborators":47,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":47,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":47,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":47,"overallStatus":66,"whyStopped":47,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Jiangsu Aidea Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: ADB116 0.03 mg\u002Fkg","EXPERIMENTAL","ADB116 for Injection 0.03mg\u002Fkg, single intravenous bolus injection",[13],"Drug: ADB116 for Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: ADB116 0.06 mg\u002Fkg","ADB116 for Injection 0.06mg\u002Fkg, single intravenous bolus injection",[13,18],"Drug: Placebo for ADB116 for Injection",{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 4: ADB116 0.12mg\u002Fkg","ADB116 for Injection 0.12mg\u002Fkg, single intravenous bolus injection",[13,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 5: ADB116 0.18mg\u002Fkg","ADB116 for Injection 0.18mg\u002Fkg, single intravenous bolus injection",[13,18],{"label":28,"type":10,"description":29,"interventionNames":30},"Cohort 6: ADB116 0.24 mg\u002Fkg","ADB116 for Injection 0.24 mg\u002Fkg， single intravenous bolus injection",[13,18],{"label":32,"type":10,"description":33,"interventionNames":34},"Cohort 3: ADB116 0.09 mg\u002Fkg","ADB116 for Injection 0.09mg\u002Fkg, single intravenous bolus injection",[13,18],[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","ADB116 for Injection","ADB116 for Injection, single intravenous bolus injection",[9,15,32,20,24,28],[42],"ADB116",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Placebo for ADB116 for Injection","Matching placebo, single intravenous bolus injection",[15,32,20,24,28],null,[49],{"name":50,"affiliation":51,"role":52},"Zhongyuan Xu, Ph.D.","Nanfang Hospital, Southern Medical University","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":47,"email":58},"Xinmin Yun, Ph.D","CONTACT","＋86 0514-87752666","yunxm@aidea.com.cn",{"name":60,"role":56,"phone":61,"phoneExt":47,"email":62},"Bing Yang, M.Sc","＋86 025-83193180","yangbing@aidea.com.cn",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"NanFang Hospital of Southern Medical University","RECRUITING","Guangzhou","Guangdong","510515","China","CN",{"type":73,"coordinates":74},"Point",[75,76],113.25,23.11667,{"lat":76,"lon":75},[79],{"name":50,"role":56,"phone":80,"phoneExt":47,"email":81},"+86 13926186470","nflcyljd@smu.edu.cn",{"type":83,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100649091","phase-1-safety-tolerability-and-pharmacokinetic-evaluation-of-adb116-for-injection-100649091",false,"NCT07729839","Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection","Study of Safety, Tolerability, and Pharmacokinetics of ADB116 for Injection in Healthy Chinese Adults: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Phase I Clinical Trial","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF) prior to any study procedures and be able to comply with the protocol requirements.\n2. Aged between 18 and 45 years (inclusive of 18 years up to but not including 46 years) at the time of signing the ICF, male or female.\n3. At screening, male subjects must weigh ≥50.0 kg, female subjects must weigh ≥45.0 kg, and body mass index (BMI) = weight (kg) \u002F height² (m²) must be within the range of 19.0-26.0 kg\u002Fm² (inclusive).\n4. No history of major medical or surgical diseases prior to screening, and results of vital signs, physical examination, 12-lead ECG, laboratory tests, fundoscopic examination, chest X-ray, and abdominal ultrasound during the screening period must be normal or, if slightly outside the normal reference range, considered clinically insignificant by the investigator.",true,"ALL","18 Years","45 Years",{"count":96,"type":97},34,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","A Phase I Study of ADB116 for Injection in Healthy Chinese Adults. This study aims as follows:\n\nPrimary Objective:\n\n• To evaluate the safety and tolerability of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults.\n\nSecondary Objective:\n\n• To evaluate the pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection.",[103],"Healthy Adult Participants","2026-08-03",{"date":106,"type":107},"2026-08-05","ACTUAL",{"date":109,"type":107},"2026-05-31",{"date":111,"type":97},"2027-03-18",{"name":5,"class":6},1]