[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571123":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":61,"responsibleParty":82,"collaborators":46,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":46,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":46,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":64,"whyStopped":46,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Shanghai Huaota Biopharmaceutical Co., Ltd.","INDUSTRY",[8,14,17,20,23,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Comparator: HB0034 dose group 1","EXPERIMENTAL","6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody",[13],"Drug: HB0034",{"label":15,"type":10,"description":11,"interventionNames":16},"Active Comparator: HB0034 dose group 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Active Comparator: HB0034 dose group 3",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Active Comparator: HB0034 dose group 4",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Active Comparator: HB0034 dose group 5",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Active Comparator: HB0034 dose group 6","8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Active Comparator: HB0034 dose group 7","8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody",[13],{"label":35,"type":36,"description":37,"interventionNames":38},"Placebo group","PLACEBO_COMPARATOR","17 subjects receive placebo",[39],"Drug: HB0034 matching placebo",[41,47],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","HB0034","Recombinant Humanized Anti-IL-36R Monoclonal antibody",[9,15,18,21,24,27,31],null,{"type":42,"name":48,"description":49,"armGroupLabels":50,"otherNames":46},"HB0034 matching placebo","HB0034 matching Palcebo",[35],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":46,"email":56},"Yuan Tang","CONTACT","+86 15821321563","yuan.tang@huaota.com",{"name":58,"role":54,"phone":59,"phoneExt":46,"email":60},"Qiaoxia Qian","+86 18555690860","qiaoxia.qian@huaota.com",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":46,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Central Hospital affiliated to Shandong First Medical University","RECRUITING","Jinan","Shandong","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.99722,36.66833,{"lat":73,"lon":72},[76,80],{"name":77,"role":54,"phone":78,"phoneExt":46,"email":79},"Li Cuigang","+860531-55566416","zxyyywsy@163.com",{"name":81,"role":54,"phone":46,"phoneExt":46,"email":46},"Qing Wen",{"type":83,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100571123","phase-1-a-study-to-evaluate-hb0034-in-healthy-chinese-adult-participants-100571123",false,"NCT06716151","A Study to Evaluate HB0034 in Healthy Chinese Adult Participants","A Phase I, Randomized, Double-blind, Placebo-controlled, Single\u002Fmulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects","Inclusion Criteria:\n\n* Healthy male or female subjects age ≥ 18 and ≤ 55 years.\n* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg\u002Fm².\n* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.\n\nSigned and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.\n\nExclusion Criteria:\n\n\\- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.\n\nCurrent or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)\n\n* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).\n* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.\n* Further exclusion criterias apply.",true,"ALL","18 Years","45 Years",{"count":96,"type":97},60,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.",[103],"Healthy",[105],"Healthy subjects","2025-01-16",{"date":108,"type":109},"2025-01-20","ACTUAL",{"date":111,"type":109},"2024-12-06",{"date":113,"type":97},"2025-11-20",{"name":5,"class":6},1]