[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610635":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":11,"studyPopulation":11,"armGroups":39,"interventions":50,"overallOfficials":11,"centralContacts":60,"locations":69,"responsibleParty":95,"collaborators":11,"id":97,"slug":11,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":11,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":11,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":11,"overallStatus":116,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Beijing Suncadia Pharmaceuticals Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse events (AEs)",null,"Approximately 16 weeks.",[14,16,18,20,22,24,26],{"measure":15,"description":11,"timeFrame":12},"Area under the concentration-time curve from time 0 to the last time point (AUC0-last)",{"measure":17,"description":11,"timeFrame":12},"Area under the concentration-time curve from time 0 to infinity (AUC0-inf)",{"measure":19,"description":11,"timeFrame":12},"Maximum observed concentration (Cmax)",{"measure":21,"description":11,"timeFrame":12},"Time to maximum observed concentration (Tmax)",{"measure":23,"description":11,"timeFrame":12},"Apparent clearance (CL\u002FF)",{"measure":25,"description":11,"timeFrame":12},"Apparent volume of distribution (Vd\u002FF)",{"measure":27,"description":11,"timeFrame":12},"Terminal elimination half-life (t1\u002F2)",{"allocation":29,"interventionModel":30,"interventionModelDescription":11,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":11,"whoMasked":34},"QUADRUPLE",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[40,45],{"label":41,"type":42,"description":11,"interventionNames":43},"SHR-4658 Group","EXPERIMENTAL",[44],"Drug: SHR-4658 Injection.",{"label":46,"type":47,"description":11,"interventionNames":48},"SHR-4658 Placebo Group","PLACEBO_COMPARATOR",[49],"Drug: SHR-4658 Placebo Injection",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"DRUG","SHR-4658 Injection.","SHR-4658 injection.",[41],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":11},"SHR-4658 Placebo Injection","SHR-4658 placebo injection.",[46],[61,66],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},"Miao Guo","CONTACT","+86-0518-82342973","miao.guo.mg19@hengrui.com",{"name":67,"role":63,"phone":64,"phoneExt":11,"email":68},"Shuai Jiang","shuai.jiang.sj5@hengrui.com",[70],{"facility":71,"status":11,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Beijing Anzhen Hospital Capital Medical University","Beijing","Beijing Municipality","100029","China","CN",{"type":78,"coordinates":79},"Point",[80,81],116.39723,39.9075,{"lat":81,"lon":80},[84,88,92,94],{"name":85,"role":63,"phone":86,"phoneExt":11,"email":87},"Yang Lin","+86-010-64456045","linyang@anzhengcp.com",{"name":89,"role":63,"phone":90,"phoneExt":11,"email":91},"Shan Jing","+86-010-64456014","jingshan@anzhengcp.com",{"name":85,"role":93,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":89,"role":93,"phone":11,"phoneExt":11,"email":11},{"type":96,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610635",false,"NCT07230145","A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure","A Double-Blind, Randomized, Dose-Escalating Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent.\n2. Blood pressure as defined in the protocol.\n3. Male or female，aged 18 to 55 years (inclusive).\n4. Meet the weight standard.\n\nExclusion Criteria:\n\n1. Known history or current clinically significant disease.\n2. Protocol-defined risk factors for disease.\n3. Participated in clinical trials of other drugs or medical devices.\n4. Pregnant or nursing women.",true,"ALL","18 Years","55 Years",{"count":108,"type":109},48,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of single subcutaneous injection of SHR-4658 in healthy volunteers and volunteers with elevated blood pressure.",[115],"Heart Failure","NOT_YET_RECRUITING","2025-11-13",{"date":119,"type":120},"2025-11-17","ACTUAL",{"date":122,"type":109},"2025-11",{"date":124,"type":109},"2026-07",{"name":5,"class":6},1]