[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Yirui Pharmaceutical Technology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"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",[28],"Health Adult Subjects",[30,31,32],"Phase 1","Double-Blind","Safety and Tolerability","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2026-06-22",{"date":41,"type":22},"2026-11-11",{"name":43,"class":44},"Hangzhou Yirui Pharmaceutical Technology Co., Ltd","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100614928","phase-1-a-first-in-human-sad-and-mad-study-in-healthy-participants-to-evaluate-oral-yr011-tablet-100614928","NCT07285967","A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet","A First-in-Human, Randomized, Double-Blinded, Placebo Controlled, SAD and MAD Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR011 Following Oral Administration.","Inclusion Criteria:\n\n* Participants who meet all the following criteria could be enrolled in this study:\n\n  1. Written informed consent obtained from the participant in compliance with all local legal requirements.\n  2. Male or female participant aged between 18 and 60 years (extremes included).\n  3. Body mass index (BMI) between 18-32 kg\u002Fm2 (extremes included) and body weight less than 120 kg.\n  4. Males must use a condom or remain abstinent during the trial and for 3 months after their last dose of study medication. And a fertile man's female partner must not try to become pregnant during the study.\n  5. Female participants of childbearing potential must be established on a highly effective method of contraception (The recommended birth control methods are: Implantable (e.g. Implanon(r)), injectable (e.g. Depo-Provera(r)), insertable (e.g. NuvaRing®), Mirena (r) (LNG-IUS)), Combined oral contraceptives pill or progestin-only pill, Evra patch®, Intrauterine device (e.g. ParaGard(r), copper T) or Female sterilization, Male sterilization. The recommended birth control methods must be taken at least 3 weeks prior to screening (i.e., to ensure the contraceptive method has taken effect).) prior to dosing and until 3 months after their last dose in combination with male partner's use of a condom during the trial and for 3 months after the last dose.\n  6. Free from any clinically relevant illness or disease that may adversely affect the safety of the participant, or the integrity of the study as determined by medical history, physical examination, safety laboratory, and other assessments.\n  7. Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Without other intestinal diseases such as irritable bowel syndrome and acute diarrhea due to any infection.\n\nExclusion Criteria:\n\n* If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:\n\n  1. Pregnant or lactating women.\n  2. Participants with dysphagia.\n  3. Severe infections requiring parenteral antibiotics treatment within 4 weeks prior to screening, e.g. sepsis, or severe pneumonia.\n  4. Any clinically relevant conditions e.g. cerebral stroke, myocardial infarction, heart failure, unstable angina, and severe heart rate abnormalities within 6 months before screening.\n  5. History or presence (within 6 months) of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n  6. Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  7. Presence of any renal impairment or dysfunction (i.e. estimated glomerular filtration rate (eGFR)\\\u003C90 mL\u002F min).\n  8. Presence of hepatic impairment: Child-Pugh A, B or C and\u002For transaminase levels that are outside the upper normal limit (i.e., Serum bilirubin ≥1.5× upper limit of normal (ULN), ALT or AST levels \\> ULN).\n  9. diagnosis of diabetes regardless the degree of control at screening visit\n  10. Hyperthyroidism or hypothyroidism.\n  11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.\n  12. Any major surgery within 6 months of screening.\n  13. Participant has a positive test result of HBV (positive HBsAg), HCV (positive anti-HCV), or human immunodeficiency virus I and II (positive anti-HIV I\u002FII), Treponema Pallidum antibody (positive anti-TP) at screening.\n  14. Participants with innate or acquired immune system defects.\n  15. Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  16. Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or a medically qualified sub-investigator.\n  17. Participant has a QT interval with Fridericia's correction method (QTcF) \\>450 ms (males) or\\>470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit; or history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); or the use of concomitant medications that prolong the QT\u002FQTc interval.\n  18. Participant has a history of a major psychiatric illness or currently receiving therapy for a psychiatric condition Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.\n  19. Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal \\[including traditional Chinese medicinal products\\] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration. etc.","60 Years",{"count":55,"type":22},64,[25],"This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants.\n\nThe trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8.\n\nKey procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.\n\nThe trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.",[59,60,61],"Safety","Tolerability","Pharmacokinetics",[63,64,65,66],"KV1.3","YIRUI pharma","yirui","Healthy Volunteers","NOT_YET_RECRUITING","2025-12-18",{"date":70,"type":37},"2025-12-26",{"date":72,"type":22},"2026-04-01",{"date":74,"type":22},"2026-12-31",{"name":43,"class":44},""]