[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657387":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":37,"interventions":62,"overallOfficials":11,"centralContacts":77,"locations":86,"responsibleParty":105,"collaborators":11,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":11,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":11,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":11,"overallStatus":89,"whyStopped":11,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Adverse Events",null,"Through 24 weeks, up to approximately 12 months",[14,17,20,23,25],{"measure":15,"description":11,"timeFrame":16},"Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016","Predose, early post-dose and up to 48 hours postdose",{"measure":18,"description":11,"timeFrame":19},"Plasma PK: Area Under the Concentration Versus Time Curve (AUC) of IBI3016","Predose, Day 1, and up to 48 hours postdose",{"measure":21,"description":11,"timeFrame":22},"Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessed by OBP and ABPM","Baseline, Month 3 and Month 6",{"measure":24,"description":11,"timeFrame":12},"Change from baseline in serum angiotensinogen (AGT) concentration",{"measure":26,"description":11,"timeFrame":19},"Urine PK parameter: drug accumulation",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":33},"TRIPLE",[34,35,36],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[38,44,48,52,58],{"label":39,"type":40,"description":41,"interventionNames":42},"IBI3016 Dose1","EXPERIMENTAL","single doses of IBI3016 administered by subcutaneous injection",[43],"Drug: IBI3016 Dose 1",{"label":45,"type":40,"description":41,"interventionNames":46},"IBI3016 Dose 2",[47],"Drug: IBI3016 Dose 2",{"label":49,"type":40,"description":41,"interventionNames":50},"IBI3016 Dose4",[51],"Drug: IBI3016 Dose 4",{"label":53,"type":54,"description":55,"interventionNames":56},"Placebo","PLACEBO_COMPARATOR","single doses of Placebo administered by subcutaneous injection",[57],"Drug: Placebo",{"label":59,"type":40,"description":41,"interventionNames":60},"IBI3016 Dose3",[61],"Drug: IBI3016 Dose 3",[63,67,70,72,75],{"type":64,"name":65,"description":41,"armGroupLabels":66,"otherNames":11},"DRUG","IBI3016 Dose 4",[49],{"type":64,"name":68,"description":41,"armGroupLabels":69,"otherNames":11},"IBI3016 Dose 3",[59],{"type":64,"name":45,"description":41,"armGroupLabels":71,"otherNames":11},[45],{"type":64,"name":73,"description":41,"armGroupLabels":74,"otherNames":11},"IBI3016 Dose 1",[39],{"type":64,"name":53,"description":41,"armGroupLabels":76,"otherNames":11},[53],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":11,"email":82},"Wendy Duan","CONTACT","+86 010-87412310","wenjing.duan@innoventbio.com",{"name":84,"role":80,"phone":11,"phoneExt":11,"email":85},"Congying Xia","congying.xia@innoventbio.com",[87],{"facility":88,"status":89,"city":90,"state":11,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Medical Corporation Heishinkai OPHAC Hospital","RECRUITING","Osaka","532-003","Japan","JP",{"type":95,"coordinates":96},"Point",[97,98],135.50107,34.69379,{"lat":98,"lon":97},[101],{"name":102,"role":80,"phone":103,"phoneExt":11,"email":104},"Kotaro Tsushima","+81-6-6395-9000","ophach_chiken@heishinkai.com",{"type":106,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657387","phase-1-a-study-of-ibi3016-in-japanese-participants-100657387",false,"NCT07838220","A Study of IBI3016 in Japanese Participants","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of IBI3016 in Japanese Participants With Mild to Moderate Hypertension","Inclusion Criteria:\n\n* 1\\. Male or female participants aged 18-75 years (inclusive) at the time of informed consent;\n* 2\\. Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin;\n* 3\\. Office mean sitting SBP≥ 140 mmHg and \\\u003C 170 mmHg at screening\n\nExclusion Criteria:\n\n* 1\\. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea;\n* 2\\. History of orthostatic hypotension\n* 3\\. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor\n* 4\\. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening;\n* 5\\. Presence of serious active and uncontrolled physical conditions or medical history, which may be in a dangerous state during the use of the study drug, or interfere with the interpretation of efficacy and safety data of this study, as judged by the investigator prior to randomization","ALL","18 Years","75 Years",{"count":118,"type":119},30,"ESTIMATED","INTERVENTIONAL",[122],"PHASE1","A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.",[125],"Hypertension","2026-09-17",{"date":128,"type":129},"2026-09-24","ACTUAL",{"date":131,"type":129},"2026-08-01",{"date":133,"type":119},"2027-11-05",{"name":5,"class":6},1]