[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632522":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":54,"studyPopulation":41,"armGroups":55,"interventions":76,"overallOfficials":93,"centralContacts":98,"locations":108,"responsibleParty":124,"collaborators":41,"id":126,"slug":41,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":41,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":41,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":41,"overallStatus":111,"whyStopped":41,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"JW Pharmaceutical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":41},[9,13,17,20,23,26,29,32,35,38],{"measure":10,"description":11,"timeFrame":12},"Treatment-Emergent Adverse Events (TEAEs)","Safety and tolerability will be assessed by monitoring the frequency and severity of Adverse Events (AEs). Adverse events are categorized into Pre-Treatment Adverse Events (PTAEs) and Treatment-Emergent Adverse Events (TEAEs).","SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28",{"measure":14,"description":15,"timeFrame":16},"Skin Irritation Assessment - Subjective","Evaluation of skin safety using participant-reported subjective irritation (itching, prickling, burning, stinging, and tightness).","SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28",{"measure":18,"description":19,"timeFrame":16},"Skin Irritation Assessment - Objective","Evaluation of skin safety using investigator-observed objective irritation (erythema, dryness\u002Fscaling, folliculitis, edema, and papules).",{"measure":21,"description":22,"timeFrame":16},"Systolic Blood Pressure","Systolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.",{"measure":24,"description":25,"timeFrame":16},"Diastolic Blood Pressure","Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.",{"measure":27,"description":28,"timeFrame":16},"Pulse Rate","Pulse rate will be measured in beats per minute (bpm). Any clinically significant abnormal findings will be collected as adverse events.",{"measure":30,"description":31,"timeFrame":16},"Body Temperature","Body temperature will be measured in degrees Celsius (°C). Any clinically significant abnormal findings will be collected as adverse events.",{"measure":33,"description":34,"timeFrame":16},"12-lead ECG","Safety is assessed through 12-lead ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcB. Clinically significant findings, such as rhythm abnormalities, are collected as adverse events.",{"measure":36,"description":37,"timeFrame":16},"Shift from Baseline in Laboratory Test Results","Laboratory test results are classified as normal, clinically non-significant abnormal, or clinically significant abnormal, and presented in a shift table from baseline. Measurements are performed using standard clinical laboratory methods.",{"measure":39,"description":40,"timeFrame":12},"Physical Examination (Normal\u002FAbnormal)","Physical examination findings categorized as normal or abnormal based on a comprehensive assessment including medical history review, interview, inspection, palpation, percussion, and auscultation, as assessed by the investigator.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial","TREATMENT",{"masking":48,"maskingDescription":41,"whoMasked":49},"QUADRUPLE",[50,51,52,53],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The study is divided into two parts:\n\n* Part 1 (Korean Healthy Adults): Consists of 5 cohorts each for Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) stages.\n* Part 2 (Caucasian Healthy Adults): Consists of 2 cohorts each for SAD and MAD stages to evaluate the drug in a different ethnic group.",[56,63,68,72],{"label":57,"type":58,"description":59,"interventionNames":60},"Part 1: SAD","EXPERIMENTAL","Up to five cohorts (S1-S5) (n = 40). Conducted in healthy Korean adults.",[61,62],"Drug: JW0061 SAD","Drug: Placebo",{"label":64,"type":58,"description":65,"interventionNames":66},"Part 1: MAD","Up to five cohorts (M1-M5) (n = 40). Conducted in healthy Korean adults.",[67,62],"Drug: JW0061 MAD",{"label":69,"type":58,"description":70,"interventionNames":71},"Part 2: SAD","Up to two cohorts (S6-S7) (n = 12). Conducted in healthy Caucasian adults.",[61],{"label":73,"type":58,"description":74,"interventionNames":75},"Part 2: MAD","Up to two cohorts (M6-M7) (n = 12). Conducted in healthy Caucasian adults.",[67],[77,84,89],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","JW0061 SAD","Single ascending doses",[57,69],[83],"JW0061",{"type":78,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"JW0061 MAD","Multiple ascending doses",[64,73],[83],{"type":78,"name":90,"description":91,"armGroupLabels":92,"otherNames":41},"Placebo","Matching placebo for JW0061",[64,57],[94],{"name":95,"affiliation":96,"role":97},"Seung Hwan Lee","Seoul National University Hospital","PRINCIPAL_INVESTIGATOR",[99,104],{"name":100,"role":101,"phone":102,"phoneExt":41,"email":103},"Soyeon Jeong","CONTACT","+82-2-840-6797","soyoun1628@jwhealthcare.com",{"name":105,"role":101,"phone":106,"phoneExt":41,"email":107},"Inyoung Park","+82-2-840-6887","inyoung.park@jwhealthcare.com",[109],{"facility":110,"status":111,"city":112,"state":112,"zip":113,"country":114,"countryCode":41,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Seoul National University Hospital Clinical Trial Center","RECRUITING","Seoul","110-744","South Korea",{"type":116,"coordinates":117},"Point",[118,119],126.9784,37.566,{"lat":119,"lon":118},[122],{"name":123,"role":97,"phone":41,"phoneExt":41,"email":41},"SeungHwan Lee",{"type":125,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100632522",false,"NCT07514780","To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers","A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial to Evaluate the Safety, Pharmacokinetic and Pharmadynamics of JW0061 Following Topical Application in Korean and Caucasians Healthy Adults","Inclusion Criteria:\n\n* Body weight between 50.0 kg and 90.0 kg, and BMI between 18.5 and 29.9 kg\u002Fm².\n* Determined to be healthy and eligible by the investigator based on medical history, physical examination, and clinical laboratory tests.\n* Capable of providing written informed consent and willing to comply with all study requirements and restrictions.\n\nExclusion Criteria:\n\n* Presence of clinically significant scalp conditions that may interfere with safety assessments.\n* History of malignancy within 5 years prior to screening.\n* History of hypersensitivity or allergy to the study drug or its components.",true,"ALL","19 Years","55 Years",{"count":137,"type":138},104,"ESTIMATED","INTERVENTIONAL",[141],"PHASE1","This clinical study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation clinical trial to evaluate the safety, pharmacokinetic and pharmacodynamics of JW0061 following topical application in Korean and Caucasians healthy adults.",[144],"Healthy","2026-04-20",{"date":147,"type":148},"2026-04-23","ACTUAL",{"date":150,"type":148},"2026-04-13",{"date":152,"type":138},"2027-04-30",{"name":5,"class":6},1]