[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616109":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":11,"studyPopulation":11,"armGroups":44,"interventions":55,"overallOfficials":11,"centralContacts":63,"locations":69,"responsibleParty":90,"collaborators":11,"id":92,"slug":11,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":11,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence and severity of adverse events",null,"from ICF signing date to Day 14 or Day 21 or Day 27",[14,17,19,21,23,25,27,30],{"measure":15,"description":11,"timeFrame":16},"AUC of HRS-6257","0 hour to 72 hour after administration",{"measure":18,"description":11,"timeFrame":16},"Cmax of HRS-6257",{"measure":20,"description":11,"timeFrame":16},"Tmax of HRS-6257",{"measure":22,"description":11,"timeFrame":16},"t1\u002F2 of HRS-6257",{"measure":24,"description":11,"timeFrame":16},"CL\u002FF of HRS-6257",{"measure":26,"description":11,"timeFrame":16},"Vz\u002FF of HRS-6257",{"measure":28,"description":11,"timeFrame":29},"Pain tolerance time for the Cold Pain Test","Day 1 to Day 1 or Day 14",{"measure":31,"description":11,"timeFrame":32},"Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses","from ICF signing date to Day 14",{"allocation":34,"interventionModel":35,"interventionModelDescription":11,"primaryPurpose":36,"observationalModel":11,"timePerspective":11,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":11,"whoMasked":39},"QUADRUPLE",[40,41,42,43],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[45,50],{"label":46,"type":47,"description":11,"interventionNames":48},"HRS-6257 group","EXPERIMENTAL",[49],"Drug: HRS-6257",{"label":51,"type":52,"description":11,"interventionNames":53},"placebo group","PLACEBO_COMPARATOR",[54],"Drug: placebo",[56,60],{"type":57,"name":58,"description":58,"armGroupLabels":59,"otherNames":11},"DRUG","HRS-6257",[46],{"type":57,"name":61,"description":61,"armGroupLabels":62,"otherNames":11},"placebo",[51],[64],{"name":65,"role":66,"phone":67,"phoneExt":11,"email":68},"Yuanyuan Huang","CONTACT","+0518-82342973","yuanyuan.huang@hengrui.com",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Third Xiangya Hospital of Central South University","RECRUITING","Changsha","Hunan","410013","China","CN",{"type":79,"coordinates":80},"Point",[81,82],112.97087,28.19874,{"lat":82,"lon":81},[85,88],{"name":86,"role":87,"phone":11,"phoneExt":11,"email":11},"Guoping Yang","PRINCIPAL_INVESTIGATOR",{"name":89,"role":87,"phone":11,"phoneExt":11,"email":11},"Saiying Wang",{"type":91,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":103,"type":104},80,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110],"Pain","2026-04-01",{"date":113,"type":114},"2026-04-07","ACTUAL",{"date":116,"type":114},"2025-12-30",{"date":118,"type":104},"2026-05",{"name":5,"class":6},1]