[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644718":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":64,"collaborators":33,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":33,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Hangzhou Yirui Pharmaceutical Technology Co., Ltd","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: SAD-MAD (20% BSA, BID)","EXPERIMENTAL","Single topical application of YR001 ointment or placebo at approximately 20% BSA on Day 1, followed by multiple-dose administration (twice daily from Day 3 to Day 8, once on Day 9 morning) if safety is acceptable.",[13,14],"Drug: PA032","Drug: Vehicle Ointment",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2: MAD (10% BSA, BID)","Multiple-dose topical administration of YR001 ointment or placebo at approximately 10% BSA, twice daily from Day 1 to Day 6, and once on Day 7 morning.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3: MAD (20% BSA, TID)","Multiple-dose topical administration of YR001 ointment or placebo at approximately 20% BSA, three times daily from Day 1 to Day 6, and once on Day 7 morning.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Group 4: MAD (10% BSA, TID)","Multiple-dose topical administration of YR001 ointment or placebo at approximately 10% BSA, three times daily from Day 1 to Day 6, and once on Day 7 morning.",[13,14],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","PA032","YR001 ointment containing 2% PA032 (Kv1.3 potassium channel blocker) for topical application",[9,16,20,24],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Vehicle Ointment","Matching vehicle ointment without active ingredient (identical appearance, packaging, and administration)",[9,16,20,24],[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"jiawei wang","CONTACT","086-13989498498","jiawei.wang@yirui-pharma.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hebei CNPC Central Hospital","RECRUITING","Langfang","Hebei","065000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.71471,39.52079,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":33,"email":63},"kexin zhao","086-13582771223","cnpcgcp@163.com",{"type":65,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100644718","phase-1-an-early-stage-clinical-trial-to-evaluate-the-safety-absorption-and-disposition-of-yr001-ointment-following-topical-application-on-the-skin-of-healthy-chinese-subjects-100644718",false,"NCT07673458","An Early-stage Clinical Trial to Evaluate the Safety, Absorption, and Disposition of YR001 Ointment Following Topical Application on the Skin of Healthy Chinese Subjects","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR001 Topical Ointment in Healthy Chinese Participants: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study.","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form to participate in the study.\n\nMale or female, aged 18 to 65 years (inclusive).\n\nBody weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg\u002Fm² (inclusive).\n\nSkin at the intended application area is intact without ulceration, injury, sunburn, redness, rash, or other abnormalities at screening and prior to dosing.\n\nFemale participants of childbearing potential and all male participants must agree to use effective contraceptive methods during the study and for 3 months after the last dose.\n\nNo clinically relevant diseases, including dermatological conditions, as determined by medical history, physical examination, safety laboratory tests, and other assessments, that could adversely affect participant safety or study integrity or interfere with study results.\n\nWilling and able to comply with scheduled study visits, treatment administration, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Current or history of clinically significant medical conditions or other disorders that may interfere with the assessment of safety, tolerability, or PK of YR001 Ointment, or place the participant at increased risk.\n\nPregnant or breastfeeding women, or participants with a positive pregnancy test.\n\nTattoos, scars, cuts, bruises, or other skin injuries (including excessive UV exposure) at the intended application site that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, excretion, or trial safety.\n\nDermatological diseases or infections (e.g., acne, impetigo) or skin conditions at the intended application area that may interfere with study assessments, or that the investigator considers may affect drug absorption or skin observation.\n\nUnwilling to refrain from using depilatory creams or wax on the intended application area for 2 weeks prior to dosing and throughout the study.\n\nPositive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus IgG antibody (Anti-HCV), Treponema pallidum antibody (Anti-TP), or human immunodeficiency virus antibody (Anti-HIV).\n\nExisting renal impairment as judged by the investigator.\n\nExisting hepatic impairment as judged by the investigator.\n\nParticipation in another interventional clinical trial (e.g., investigational drug, biologic, or device) within 90 days prior to baseline, or currently in the follow-up period of another study, or prior participation in this clinical trial.\n\nUse of any over-the-counter (OTC) or prescription medications (including probiotics\u002Fprebiotics, vitamins, herbal supplements, and nutraceuticals, with the exception of acetaminophen\u002Fparacetamol) within 14 days prior to baseline, or receipt of vaccination within this period.\n\nCurrently diagnosed with acute or chronic inflammatory diseases (limited to autoimmune diseases and infectious diseases, e.g., tuberculosis). Participants whose disease symptoms have resolved for ≥ 12 months without any treatment may be considered in remission and eligible for enrollment.\n\nUse of topical skin products (including emollients) at the intended application site within 48 hours prior to baseline; use of topical products on non-application sites is permitted.\n\nClinically significant cardiac conduction abnormalities on electrocardiogram (ECG) as judged by the study physician.\n\nKnown allergy to the active substance or any excipient of the ointment.\n\nAny major surgery within 6 months prior to the screening period.\n\nDiagnosis of malignancy within 5 years prior to screening, with the exception of successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n\nEmployees of the sponsor, clinical service organization, or clinical research site.\n\nHistory of drug abuse or substance use disorder within the past year; history of alcoholism within the past 6 months (as judged by the investigator); smoking \\> 5 cigarettes per day within the past 3 months, or inability to refrain from smoking during the study.\n\nAny other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the clinical trial.",true,"ALL","18 Years","65 Years",{"count":78,"type":79},18,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","The goal of this clinical trial is to evaluate the safety, local tolerability, and pharmacokinetic (PK) profile of YR001 Topical Ointment in healthy Chinese participants. This is a first-in-China, Phase I study designed to assess the drug's systemic absorption and disposition following single and multiple topical applications.\n\nThe main questions it aims to answer are:\n\nWhat is the safety and local tolerability profile of YR001 Topical Ointment after single-dose and multiple-dose administration in healthy Chinese participants?\n\nWhat are the pharmacokinetic characteristics (e.g., plasma drug concentrations) of YR001 Topical Ointment after single and multiple topical applications?\n\nResearchers will compare participants receiving YR001 Topical Ointment with participants receiving vehicle (placebo) to determine whether the safety profile and local tolerability of YR001 are comparable to placebo.\n\nParticipants will:\n\nReceive topical application of either YR001 Topical Ointment or matching placebo (vehicle) on approximately 10% or 20% of their body surface area, depending on the assigned group\n\nUndergo serial blood sampling for pharmacokinetic assessments at specified time points before and after drug administration\n\nComplete safety evaluations including physical examinations, vital signs, laboratory tests (hematology, biochemistry, coagulation, thyroid function, urinalysis), 12-lead ECGs, and local tolerability assessments at the application site\n\nRemain in the clinical unit for specified periods during the dosing and follow-up phases, with total study participation duration up to approximately 30 days per participant",[85],"Health Adult Subjects",[87,88,89],"Phase 1","Double-Blind","Safety and Tolerability","2026-06-29",{"date":92,"type":93},"2026-07-01","ACTUAL",{"date":95,"type":93},"2026-06-22",{"date":97,"type":79},"2026-11-11",{"name":5,"class":6},1]