[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564736":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":46,"locations":51,"responsibleParty":53,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":51,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":51,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":51,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":51},{"fullName":5,"class":6},"Biotech Pharmaceutical Co., Ltd.","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"JH013 injections 75mg","EXPERIMENTAL","6 subjects receive JH013 at a dose of 75 mg and 2 subjects receive the same volume placebo",[13,14],"Drug: JH013 injection","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"JH013 injections 150mg","6 subjects will receive JH013 injections 150mg，2 subjects receive the same volume placebo",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"JH013 injections 300mg","6 subjects receive JH013 at a dose of 300 mg and 2 subjects receive the same volume placebo",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"JH013 injections 500mg","6 subjects receive JH013 at a dose of 500 mg and 2 subjects receive the same volume placebo",[13,14],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","JH013 injection","JH013 injection is a BAFF-R inhibitor monoclonal antibody",[16,20,24,9],[34],"JH013",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Placebo","JH013 injections placebo",[16,20,24,9],[40],"JH013 Placebo",[42],{"name":43,"affiliation":44,"role":45},"chen Rui, Dr","Peking Union Medical College Hospital","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Wang Yucheng, Master","CONTACT","010-51571020",null,"wangyucheng@biotechplc.com",{"type":54,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100564736","phase-1-a-phase-i-clinical-trial-of-jh013-injection-100564736",false,"NCT06633055","A Phase I Clinical Trial of JH013 Injection","A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JH013 Injection in Healthy Subjects","Inclusion Criteria:\n\n* Healthy adult male or female aged 18-55 years (age including cut-off values);\n* There were no abnormalities in clinically significant vital signs, physical examination, laboratory tests, and 12-lead ECG;\n* Weight ≥ 50 kg for males and ≥45 kg for females; Body mass index (BMI) between 18.0 and 26 kg\u002Fm2 (including cut-off values, body mass index = weight\u002Fheight2);\n* Females of potential childbearing potential with a negative blood β-HCG test within 72 hours prior to dosing (postmenopausal women who have amenorrhea for at least 12 months are considered non-childbearing and women who are known to have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or ligation, and a pregnancy test is not required);\n* Subjects understand and comply with the study process, participate voluntarily, and sign the informed consent form\n\nExclusion Criteria:\n\n* Subject has a history of malignancy prior to screening, or has been screened for malignancy, and the possibility of malignancy cannot be reasonably ruled out\n* Subject has a history of autoimmune disease prior to screening\n* γ interferon release assay results ≥ 2 times the upper limit of normal\n* Any history of infection requiring hospitalization or receiving antivirals, antibiotics, antifungals, antiparasitic drugs, or vaccinations within 4 weeks prior to the application of the study drug\n* Those who have positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody or syphilis antibody\n* Patients with a history of previous and\u002For current heart disease (including New York Heart Association Class III\u002FIV heart failure), gastrointestinal, renal, endocrine, neurological, autoimmune, hematologic (including pancytopenia, aplastic anemia or anaemia, etc.), metabolic (including diabetes), severe lung disease and psychiatric illness\n* History of organ transplantation: such as heart, lung, kidney, liver, or hematopoietic stem cell transplantation",true,"ALL","18 Years","55 Years",{"count":67,"type":68},32,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","This is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects",[74],"Healthy Subjects (HS)",[76],"Dose escaltion","NOT_YET_RECRUITING","2024-10-07",{"date":80,"type":81},"2024-10-09","ACTUAL",{"date":83,"type":68},"2024-10-31",{"date":85,"type":68},"2025-12-31",{"name":5,"class":6}]