[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616109":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-6257 group","EXPERIMENTAL",null,[13],"Drug: HRS-6257",{"label":15,"type":16,"description":11,"interventionNames":17},"placebo group","PLACEBO_COMPARATOR",[18],"Drug: placebo",[20,24],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","HRS-6257",[9],{"type":21,"name":25,"description":25,"armGroupLabels":26,"otherNames":11},"placebo",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Yuanyuan Huang","CONTACT","+0518-82342973","yuanyuan.huang@hengrui.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Third Xiangya Hospital of Central South University","RECRUITING","Changsha","Hunan","410013","China","CN",{"type":43,"coordinates":44},"Point",[45,46],112.97087,28.19874,{"lat":46,"lon":45},[49,52],{"name":50,"role":51,"phone":11,"phoneExt":11,"email":11},"Guoping Yang","PRINCIPAL_INVESTIGATOR",{"name":53,"role":51,"phone":11,"phoneExt":11,"email":11},"Saiying Wang",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100616109","phase-1-a-study-of-single-and-multiple-doses-of-hrs-6257-in-healthy-subjects-100616109",false,"NCT07301333","A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects","A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects","Inclusion Criteria:\n\n1. Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.\n2. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg\u002Fm².\n3. Female subjects must be non-pregnant or non-childbearing potential;\n4. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.\n\nExclusion Criteria:\n\n1. History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;\n2. Known or suspected hypersensitivity to trial product(s) or related products;\n3. 12-lead ECG demonstrating QTcF \\>450 msec or history or risk factors for QT prolongation;\n4. Blood donation of more than 200 mL within the last 6 months\n5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives;\n6. Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.\n7. Previous administration with an investigational product (drug or vaccine) within 3 months;",true,"ALL","18 Years","55 Years",{"count":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"PHASE1","This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.",[75],"Pain","2026-04-01",{"date":78,"type":79},"2026-04-07","ACTUAL",{"date":81,"type":79},"2025-12-30",{"date":83,"type":69},"2026-05",{"name":5,"class":6},1]