[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658374":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":38,"studyPopulation":26,"armGroups":39,"interventions":50,"overallOfficials":26,"centralContacts":58,"locations":64,"responsibleParty":78,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Jemincare","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse events (AEs)","Incidence of Adverse events (AEs)","Day 1 to Day 4",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Maximum concentration (Cmax)","Cmax was the highest concentration observed directly from data",{"measure":18,"description":19,"timeFrame":12},"Area under the concentration-time curve","Reflects the actual body exposure to drug after administration of sinlge and multiple dose",{"measure":21,"description":22,"timeFrame":12},"Time to Cmax (Tmax)","Tmax was the time to reach maximum observed plasma concentration",{"measure":24,"description":25,"timeFrame":12},"Elimination half-life (t1\u002F2)","Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability, and PK characteristics of a single dose of JY1001 in healthy participants.\n\nHealthy participants will be randomized to receive JY1001 or placebo (8 participants each cohort, with a ratio of 3:1). The study includes 6 cohorts. JY1001 doses levels in each cohort will be 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, and 320 mg, respectively. Eligible participants will stay at the study center one day before administration (D-1) and receive the drug at D1. They will be discharged on D4 (72 hours after administration).\n\nDecisions on dose escalation to next cohort will be made by Safety Review Committee (SRC) consisting of investigators and sponsor representatives, based on all participants' safety and tolerability data up to 72 hours after administration and any available PK data of the previous cohort.",[40,45],{"label":41,"type":42,"description":26,"interventionNames":43},"JY1001","EXPERIMENTAL",[44],"Drug: JY1001",{"label":46,"type":47,"description":26,"interventionNames":48},"Placebo","PLACEBO_COMPARATOR",[49],"Drug: Placebo",[51,55],{"type":52,"name":41,"description":53,"armGroupLabels":54,"otherNames":26},"DRUG","Participants will receive a single dose of JY1001 (10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg) via IV at Day 1",[41],{"type":52,"name":46,"description":56,"armGroupLabels":57,"otherNames":26},"Participants will receive a single dose of placebo via IV at Day 1",[46],[59],{"name":60,"role":61,"phone":62,"phoneExt":26,"email":63},"Mengchang Yang","CONTACT","028-87394243","ymc681@126.com",[65],{"facility":66,"status":26,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":26},"Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital","Chengdu","Sichuan","610072","China","CN",{"type":73,"coordinates":74},"Point",[75,76],104.06667,30.66667,{"lat":76,"lon":75},{"type":79,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100658374","phase-1-phase-i-study-of-jy1001-injection-100658374",false,"NCT07848945","Phase I Study of JY1001 Injection","A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Character of a Single Dose of JY1001 Injection in Healthy Adult Participants","Inclusion Criteria:\n\n* Healthy male or female adult participants\n* Men ≥50kg, women ≥45kg, and body mass index (BMI) 19-28 kg\u002Fm² (inclusive)\n\nExclusion Criteria:\n\n* With any disease that the investigator judges will take risk to participants or affect the evaluation of the study.",true,"ALL","18 Years","45 Years",{"count":92,"type":93},48,"ESTIMATED","INTERVENTIONAL",[96],"PHASE1","The goal of this dose esclation study is to evaluate the safety, tolerability, and PK characteristicsafter of a single dose of JY1001 injection in healthy participants. A total of 6 cohorts are planned to be evaluated. Each cohort will enroll 8 participants to receive JY1001 or placebo in 3:1 ratio.",[99],"Pain After Surgery",[101],"dose esclation","NOT_YET_RECRUITING","2026-09-23",{"date":105,"type":106},"2026-09-30","ACTUAL",{"date":108,"type":93},"2026-11",{"date":110,"type":93},"2027-05",{"name":5,"class":6},1]