[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558299":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Jemincare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","ACTIVE_COMPARATOR","JMKX003801",[13],"Drug: JMKX003801",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator","PLACEBO_COMPARATOR","Normal saline",[19],"Drug: Placebo",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation.\n\nFor Ascending Multiple Dose of JMKX003801，Three（3）cohort of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation.\n\nFor Ascending Multiple Dose of JMKX003801，Three（3）cohorts of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.",[15],[31],{"name":32,"affiliation":33,"role":34},"Jing Zhang","Huashan Hospital","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Hongzhang Ji","CONTACT","+8618261053520","jihongzhang@jemincare.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Huashan Hospital Fudan University","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":32,"role":38,"phone":57,"phoneExt":25,"email":58},"+8613816357098","zhangj_fudan@163.com",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100558299","phase-1-trial-of-jmkx003801-in-healthy-participants-100558299",false,"NCT06549309","Trial of JMKX003801 in Healthy Participants","A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants","Inclusion Criteria:\n\n* The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol;\n* Healthy adult males and\u002For females, 18 to 45 years of age;\n* Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg\u002Fm2) ,weight ≥45kg (female) or ≥50kg (male) .\n\nExclusion Criteria:\n\n* Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, or any other diseases judged by investigators that will be interference to the results of this study;\n* Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;\n* Pregnant or lactating women;\n* Other conditions unsuitable for the trial judged by the investigators.",true,"ALL","18 Years","45 Years",{"count":73,"type":74},70,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants",[80],"Healthy",[82,83,84],"Safety","Tolerability","Pharmacokinetics","2024-09-24",{"date":87,"type":88},"2024-09-26","ACTUAL",{"date":90,"type":88},"2024-08-17",{"date":92,"type":74},"2025-06-12",{"name":5,"class":6},1]