[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628547":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":20,"studyPopulation":20,"armGroups":37,"interventions":50,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":64,"collaborators":66,"id":69,"slug":20,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":20,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":20,"overallStatus":88,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":20},{"fullName":5,"class":6},"Jemincare","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Mass balance of JMKX003142","Total recovery of radioactivity in urine and faeces following a single oral dose of \\[14C\\]-JMKX003142 (expressed as a percentage of the total radioactive dose administered)","up to 15 days (until >90% of dose is recovered)",{"measure":14,"description":15,"timeFrame":16},"Absolute bioavailability of JMKX003142 in plasma","Absolute bioavailability is calculated from the AUCs of iv and oral administration","96 hours",[18,22,24,26,28],{"measure":19,"description":20,"timeFrame":21},"Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma",null,"Day 1 to day 15 (depending on recovery of dose)",{"measure":23,"description":20,"timeFrame":21},"Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma",{"measure":25,"description":20,"timeFrame":21},"Part1: Apparent Terminal Half-Life (t1\u002F2) Of JMKX003142",{"measure":27,"description":20,"timeFrame":21},"Part1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of JMKX003142 in Plasma",{"measure":29,"description":20,"timeFrame":30},"Frequency and severity of Participants With Adverse Events (AEs)","Up to Day 30",{"allocation":32,"interventionModel":33,"interventionModelDescription":20,"primaryPurpose":34,"observationalModel":20,"timePerspective":20,"maskingInfo":35},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":20,"whoMasked":20},"NONE",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Part1: Mass Balance","EXPERIMENTAL","Participants will receive oral \\[14C\\] JMKX003142 under fasted conditions",[43],"Drug: [14C]JMKX003142",{"label":45,"type":40,"description":46,"interventionNames":47},"Part2: Absolute Bioavailability","Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV \\[14C\\]",[48,49],"Drug: JMKX003142 tablets","Drug: [14C]JMKX003142 solution for infusion",[51,56,60],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":20},"DRUG","[14C]JMKX003142","Participants will receive oral \\[14C\\]JMKX003142",[39],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":20},"JMKX003142 tablets","Participants will receive oral JMKX003142",[45],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":20},"[14C]JMKX003142 solution for infusion","Participants will receive IV \\[14C\\] JMKX003142",[45],{"type":65,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[67],{"name":68,"class":6},"Zhejiang Hangyu Pharmaceutical Co., Ltd.","100628547",false,"NCT07463053","Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers","A Study to Evaluate the Mass Balance and Absolute Bioavailability of [14C]JMKX003142 in Healthy Male Participants","Inclusion Criteria:\n\n1. Chinese healthy males.\n2. The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF).\n3. Body mass index (BMI) range of 19-26.0 kg\u002Fm² (inclusive of boundary values), with body weight not less than 55.0 kg.\n\nExclusion Criteria:\n\n1. Abnormal findings with clinical significance on comprehensive physical examination, vital signs, digital rectal examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine with occult blood, thyroid function), ophthalmological examination, 12-lead electrocardiogram, chest X-ray (posteroanterior view), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys).\n2. White blood cell count and\u002For hemoglobin below the lower limit of the normal range in complete blood count.\n3. Resting corrected QT interval (QTcF) \\>450 ms (corrected by Fridericia's formula, QTcF = QT\u002FRR\\^1\u002F3).\n4. Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen\u002Fantibody combination test positive.\n5. Subjects with gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week prior to screening.",true,"MALE","18 Years","45 Years",{"count":80,"type":81},8,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms",[87],"ADPKD (Autosomal Dominant Polycystic Kidney Disease)","NOT_YET_RECRUITING","2026-03-06",{"date":91,"type":92},"2026-03-10","ACTUAL",{"date":94,"type":81},"2026-03-18",{"date":96,"type":81},"2026-06-11",{"name":5,"class":6}]