[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654893":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":67,"studyPopulation":67,"armGroups":77,"interventions":100,"overallOfficials":67,"centralContacts":122,"locations":128,"responsibleParty":147,"collaborators":67,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":67,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":67,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":67,"overallStatus":131,"whyStopped":67,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Shanghai Minwei Biotechnology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":67},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of treatment-emergent adverse events (TEAEs)","Incidence and severity of TEAEs.","Through study completion, for at least 85 days",[14,18,21,24,27,30,34,37,40,43,46,49,52,55,59,62,65],{"measure":15,"description":16,"timeFrame":17},"Maximum Concentration (Cmax)","Cmax of MWX401.","Up to 48 hours post-dose",{"measure":19,"description":20,"timeFrame":17},"Time to Reach Maximum Concentration (Tmax)","Tmax of MWX401.",{"measure":22,"description":23,"timeFrame":17},"Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)","AUC0-t of MWX401.",{"measure":25,"description":26,"timeFrame":17},"Area Under the Curve From Time 0 to Infinity (AUC0-inf)","AUC0-inf of MWX401.",{"measure":28,"description":29,"timeFrame":17},"Elimination Half-Life (t1\u002F2)","t1\u002F2 of MWX401.",{"measure":31,"description":32,"timeFrame":33},"Cumulative Urinary Excretion (Ae)","Ae of MWX401.","Up to 72 hours post-dose",{"measure":35,"description":36,"timeFrame":33},"Cumulative Urinary Excretion from 0 to 48 hours (Ae0-48h)","Ae0-48h of MWX401",{"measure":38,"description":39,"timeFrame":33},"Fraction of Dose Excreted in Urine (Ae%)","Ae% of MWX401.",{"measure":41,"description":42,"timeFrame":33},"Fractional Excretion (Fe)","Fe of MWX401.",{"measure":44,"description":45,"timeFrame":33},"Renal Clearance (CLr)","CLr of MWX401.",{"measure":47,"description":48,"timeFrame":12},"Change from Baseline in Serum Angiotensinogen (AGT)","Change value and percentage change from baseline in serum AGT.",{"measure":50,"description":51,"timeFrame":12},"Change from Baseline in Other RAAS Component Biomarkers","Change value and percentage change from baseline in other RAAS component (PRA, PRC, Ang I, Ang II, or ALD) biomarkers.",{"measure":53,"description":54,"timeFrame":12},"Change from Baseline in Blood Pressure","Change in systolic and diastolic blood pressure from baseline throughout the study.",{"measure":56,"description":57,"timeFrame":58},"Change from Baseline in 24-hour Ambulatory Blood Pressure","Changes in mean systolic and mean diastolic blood pressure from baseline throughout the study.","Up to Day 85",{"measure":60,"description":61,"timeFrame":12},"Change from Baseline in Stroke Volume","Change from baseline in stroke volume.",{"measure":63,"description":64,"timeFrame":12},"Change from Baseline in Systemic Vascular Resistance","Change from baseline in systemic vascular resistance.",{"measure":66,"description":67,"timeFrame":12},"Detect anti-drug antibodies (ADA)",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":67,"primaryPurpose":71,"observationalModel":67,"timePerspective":67,"maskingInfo":72},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":73,"maskingDescription":67,"whoMasked":74},"DOUBLE",[75,76],"PARTICIPANT","INVESTIGATOR",[78,84,88,92,96],{"label":79,"type":80,"description":67,"interventionNames":81},"MWX401 Cohort 1","EXPERIMENTAL",[82,83],"Drug: MWX401 1","Drug: Placebo",{"label":85,"type":80,"description":67,"interventionNames":86},"MWX401 Cohort 2",[87,83],"Drug: MWX401 2",{"label":89,"type":80,"description":67,"interventionNames":90},"MWX401 Cohort 3",[91,83],"Drug: MWX401 3",{"label":93,"type":80,"description":67,"interventionNames":94},"MWX401 Cohort 4",[95,83],"Drug: MWX401 4",{"label":97,"type":80,"description":67,"interventionNames":98},"MWX401 Cohort 5",[99,83],"Drug: MWX401 5",[101,106,110,113,116,119],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":67},"DRUG","MWX401 1","Administered subcutaneously (SC)",[79],{"type":102,"name":107,"description":108,"armGroupLabels":109,"otherNames":67},"MWX401 2","Administered SC",[85],{"type":102,"name":111,"description":108,"armGroupLabels":112,"otherNames":67},"MWX401 3",[89],{"type":102,"name":114,"description":108,"armGroupLabels":115,"otherNames":67},"MWX401 4",[93],{"type":102,"name":117,"description":108,"armGroupLabels":118,"otherNames":67},"MWX401 5",[97],{"type":102,"name":120,"description":108,"armGroupLabels":121,"otherNames":67},"Placebo",[79,85,89,93,97],[123],{"name":124,"role":125,"phone":126,"phoneExt":67,"email":127},"Wanxiang Chen","CONTACT","+86 13359015677","chenwanxiang@minweibiotech.com",[129],{"facility":130,"status":131,"city":132,"state":133,"zip":67,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":141,"contacts":142},"The Affiliated Sir Run Run Hospital, Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":137,"coordinates":138},"Point",[139,140],118.77778,32.06167,{"lat":140,"lon":139},[143],{"name":144,"role":125,"phone":145,"phoneExt":67,"email":146},"Yuwen Su, Doctor","+86 13776688046","13776688046@163.com",{"type":148,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100654893","phase-1-phase-1-clinical-study-of-mwx401-injection-in-chinese-healthy-participants-and-participants-with-mild-hypertension-100654893",false,"NCT07803835","Phase 1 Clinical Study of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 60 years (inclusive) at the time of signing the informed consent form (ICF).\n2. Body mass index (BMI) within 19.0 to 30.0 kg\u002Fm\\^2 (inclusive) at screening, with body weight \\>= 50 kg.\n3. No use of antihypertensive medications within 30 days prior to signing the ICF, including beta-blockers, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), angiotensin receptor-neprilysin inhibitors (ARNIs), and diuretics.\n4. At screening and baseline, average seated office blood pressure: healthy participants: SBP 120-139 mmHg (inclusive) and DBP 75-89 mmHg (inclusive); participants with mild hypertension: SBP 140-159 mmHg (inclusive) and DBP 90-99 mmHg (inclusive).\n\n5.12-lead electrocardiogram results normal or judged by the investigator as abnormal without clinical significance, with QTcF (Fridericia's formula) \\\u003C 450 ms (male) or \\\u003C 470 ms (female).\n\n6\\. Voluntarily sign the ICF before any study-related procedure, able to understand and willing to comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. History or evidence of secondary hypertension, including renal parenchymal hypertension, renovascular hypertension, aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, drug-induced hypertension, etc.\n2. History of type 1 or type 2 diabetes mellitus.\n3. Pulse\u002Fheart rate \\\u003C55 bpm or \\>100 bpm at screening.\n4. eGFR (CKD-EPI) \\\u003C80 mL\u002Fmin\u002F1.73 m² at screening.\n5. Body weight loss \\>5% within 6 months before screening, or planned weight loss during study.\n6. History of or current orthostatic hypotension (SBP drop ≥20 mmHg or DBP drop ≥10 mmHg within 1 min of standing from supine).\n7. History of syncope before screening.\n8. Use of prescription drugs, herbal products, or dietary supplements that may affect safety or data integrity within 30 days before randomization.\n9. Excessive blood pressure fluctuation (SBP fluctuation \\>20 mmHg during screening).\n10. History of needle phobia, difficult blood sampling, or intolerance to venipuncture.\n11. Any other condition deemed unsuitable for study by investigator.",true,"ALL","18 Years","60 Years",{"count":161,"type":162},46,"ESTIMATED","INTERVENTIONAL",[165],"PHASE1","This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase 1 clinical study, aimed at evaluating the safety, tolerability, PK, PD and immunogenicity of single subcutaneous administration of MWX401 Injection in healthy Chinese participants and participants with primary mild hypertension.\n\nThe study comprises five dose cohorts with a planned enrollment of 46 subjects. The primary endpoint is the incidence and severity of treatment-emergent adverse events. Secondary endpoints include plasma and urinary PK parameters, changes in serum AGT and RAAS components, changes in blood pressure and hemodynamics, and immunogenicity indicators.",[168,169],"Essential Hypertension","Healthy Volunteers","2026-09-03",{"date":172,"type":173},"2026-09-08","ACTUAL",{"date":175,"type":173},"2026-03-19",{"date":177,"type":162},"2026-12",{"name":5,"class":6},1]