[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565377":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":26,"locations":32,"responsibleParty":45,"collaborators":23,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":23,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":23,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":70,"whyStopped":23,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ebronucimab 150mg (after the change)","EXPERIMENTAL","Ebronucimab 150mg Single subcutaneous injection into the abdomen.",[13],"Drug: Ebronucimab",{"label":15,"type":10,"description":11,"interventionNames":16},"Ebronucimab 150mg (before the change)",[13],[18,24],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Ebronucimab","Ebronucimab subcutaneous injection",[9],null,{"type":19,"name":20,"description":21,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":23,"email":31},"Guoqin Wang","CONTACT","+86 (0760) 8987 3999","global.trials@akesobio.com",[33],{"facility":34,"status":23,"city":35,"state":36,"zip":23,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":23},"The Third Xiangya Hospital of Central South University","Changsha","Hunan","China","CN",{"type":40,"coordinates":41},"Point",[42,43],112.97087,28.19874,{"lat":43,"lon":42},{"type":46,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100565377","phase-1-a-study-evaluating-the-single-subcutaneous-injection-of-ebronucimab-in-chinese-healthy-male-subjects-100565377",false,"NCT06641388","A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects","A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects","Key Inclusion Criteria:\n\n* Weight: 60\\~80kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg \u002Fm2 for healthy Chinese male subjects.\n* Subjects fully understand the purpose, content, process, and potential adverse events of the trial, voluntarily participate in the trial, and sign an informed consent form before any trial procedure begins.\n* Low density lipoprotein cholesterol (LDL-C) levels ≥ 1.8mmol\u002FL and ≤ 4.9mmol\u002FL during screening.\n* Subjects are able to communicate well with the investigator and understand the requirements of the study.\n\nKey Exclusion Criteria:\n\n* 12 months prior use of PCSK9 inhibitors treatment.\n* Allergic to the components of Ebronucimab and any monoclonal antibodies.\n* History of important organ transplantation (such as heart, lung, liver, kidney, etc.).\n* Abnormal vital signs during screening period and before randomization.\n* Drug abuse prior to screening.",true,"MALE","18 Years","45 Years",{"count":59,"type":60},180,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.",[66],"Healthy Subjects (HS)",[68,69],"phase I","healthy subjects","NOT_YET_RECRUITING","2024-10-12",{"date":73,"type":74},"2024-10-15","ACTUAL",{"date":76,"type":60},"2024-11-04",{"date":78,"type":60},"2025-06-17",{"name":5,"class":6},1]