[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511683":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-10390","EXPERIMENTAL","Single or multiple dosing of HS-10390 in a fastingstate",[13],"Drug: HS-10390 tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo","Single or multiple dosing of placebo in a fastingstate",[18],"Drug: Placebo tablet",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","HS-10390 tablet","Oral administration of specified dose of HS-10390",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo tablet","Oral administration of matching dose ofplacebo",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Bicheng Liu","CONTACT","18001580838","liubc64@163.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Zhongda Hospital, Affiliated to Southeast University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":45,"coordinates":46},"Point",[47,48],118.77778,32.06167,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Ren Zhou","025-83272015","zdll2015@163.com",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100511683","phase-1-a-first-in-human-study-to-evaluate-safety-tolerability-pharmacology-of-hs-10390-in-healthy-subjects-100511683",false,"NCT05942625","A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects","Inclusion Criteria:\n\n* Healthy male or female subjects between the ages of 18-45 years\n* Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing\n* Have signed the informed consent form approved by the IRB\n\nExclusion Criteria:\n\n* History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and\u002For excretion of the studydrug, determined by the investigator\n* Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis\n* Have a history of or current allergic disease\n* Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse\n* Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine\n* Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests\n* Pregnant or breastfeeding female subjects",true,"ALL","18 Years","45 Years",{"count":69,"type":70},84,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.",[76,77],"IgA Nephropathy","Focal Segmental Glomerulosclerosis",[9,79,80,81,82],"Safety","Tolerability","Pharmacokinetics","Pharmacodynamics","2024-10-07",{"date":85,"type":86},"2024-10-09","ACTUAL",{"date":88,"type":86},"2023-05-23",{"date":90,"type":70},"2024-12-30",{"name":5,"class":6},1]