[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635754":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":48,"studyPopulation":16,"armGroups":49,"interventions":70,"overallOfficials":16,"centralContacts":81,"locations":90,"responsibleParty":112,"collaborators":16,"id":114,"slug":16,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":16,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":16,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":16,"overallStatus":132,"whyStopped":16,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Safety indicators-Number of Participants with Adverse Events (AEs)","up to approximately 12 months","from baseline to week 12",[14,17,19,21,23,25,27,29,31,33,35],{"measure":15,"description":16,"timeFrame":12},"Plasma pharmacokinetic parameters-peak concentration（Cmax）",null,{"measure":18,"description":16,"timeFrame":12},"Urinary pharmacokinetic parameters-drug amount excreted(Ae)",{"measure":20,"description":16,"timeFrame":12},"Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by 24-hour ambulatory blood pressure monitoring",{"measure":22,"description":16,"timeFrame":12},"Plasma pharmacokinetic parameters-Time to peak concentration（Tmax）",{"measure":24,"description":16,"timeFrame":12},"Plasma pharmacokinetic parameters-AUC（0-last）",{"measure":26,"description":16,"timeFrame":12},"Plasma pharmacokinetic parameters- AUC（0-inf）",{"measure":28,"description":16,"timeFrame":12},"Plasma pharmacokinetic parameters- half-life",{"measure":30,"description":16,"timeFrame":12},"Urinary pharmacokinetic parameters-Fraction Excreted(Fe)",{"measure":32,"description":16,"timeFrame":12},"Urinary pharmacokinetic parameters-Renal Clearance rate (CLr)",{"measure":34,"description":16,"timeFrame":12},"Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by mean sitting blood pressure (msBP)",{"measure":36,"description":16,"timeFrame":12},"Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by home blood pressure monitoring (HBPM)",{"allocation":38,"interventionModel":39,"interventionModelDescription":16,"primaryPurpose":40,"observationalModel":16,"timePerspective":16,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":16,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study is a double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension. The study plans to enroll approximately 30 subjects with mild to moderate hypertension (msSBP ≥140 mmHg and ≥170 mmHg) receiving antihypertensive medication. Eligible subjects will be randomly assigned in a 1:1:1:1:1 ratio to either the IBI3016 dose 1 group, the IBI3016 dose 2 group, the IBI3016 dose 3 group, the IBI3016 dose 4 group, or the placebo group. The entire trial period includes a 6-week screening period, a 12-week safety follow-up period, and an extended follow-up period.",[50,56,59,62,65],{"label":51,"type":52,"description":53,"interventionNames":54},"IBI3016 dose 4","EXPERIMENTAL","subcutaneous injection",[55],"Drug: IBI3016",{"label":57,"type":52,"description":53,"interventionNames":58},"IBI3016 dose 3",[55],{"label":60,"type":52,"description":53,"interventionNames":61},"IBI3016 dose 2",[55],{"label":63,"type":52,"description":53,"interventionNames":64},"IBI3016 dose 1",[55],{"label":66,"type":67,"description":53,"interventionNames":68},"placebo","PLACEBO_COMPARATOR",[69],"Other: Placebo",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":16},"DRUG","IBI3016","Solution of Injection",[63,60,57,51],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":16},"OTHER","Placebo","0.9% sodium chloride saline solution",[66],[82,87],{"name":83,"role":84,"phone":85,"phoneExt":16,"email":86},"Andy Guo","CONTACT","0512-69566088","andy.guo@innoventbio.com",{"name":88,"role":84,"phone":85,"phoneExt":16,"email":89},"Jinling Fan","jinling.fan@innoventbio.com",[91],{"facility":92,"status":16,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Beijing Anzhen Hospital, Capital Medical University","Beijing","Beijing Municipality","100029","China","CN",{"type":99,"coordinates":100},"Point",[101,102],116.39723,39.9075,{"lat":102,"lon":101},[105,109],{"name":106,"role":84,"phone":107,"phoneExt":16,"email":108},"yang lin","010-81992130","linyang3623@163.com",{"name":110,"role":84,"phone":107,"phoneExt":16,"email":111},"shan Jing","jingshan@anzhengcp.com",{"type":113,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100635754",false,"NCT07556796","Study of IBI3016 in People With Mild or Moderate Hypertension Patients","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Features of a Single Subcutaneous Administration of IBI3016 in Patients With Mild or Moderate Hypertension in China","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Males or females aged 18 to 75 years. 3 Diagnosed primary hypertension who have not been taking anti-hypertensive medication within 4 weeks prior to informed consent.\n\n4.Mean sitting SBP ≥140 mmHg and \\\u003C 170 mmHg measured by OBPM. 5.Participants able to understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. Known history of secondary hypertension.\n2. Orthostatic hypotension.\n3. Laboratory parameter assessments outside of range at screening：\n\n   * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \\> 2× Upper Limit of Normal (ULN)\n   * Total Bilirubin \\> 1.5× ULN\n   * International Normalized Ratio (INR) \\> 2.0\n   * Serum Potassium \\> 5 mmol\u002FL\n   * Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL\u002Fmin\u002F1.73m²\n   * QTcF \\> 480 ms\n4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.\n5. Current or history of intolerance to ACEi and\u002For ARBs.\n6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening, or a previous diagnosis of decompensated heart failure or New York Heart Association (NYHA) grade III or IV heart failure.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years","75 Years",{"count":124,"type":125},30,"ESTIMATED","INTERVENTIONAL",[128],"PHASE1","A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension.",[131],"Hypertension","NOT_YET_RECRUITING","2026-04-22",{"date":135,"type":136},"2026-04-29","ACTUAL",{"date":138,"type":125},"2026-05-15",{"date":140,"type":125},"2027-10-16",{"name":5,"class":6},1]