protocolSection identificationModule nctId: NCT06361108, orgStudyIdInfo id: YJ001-103, briefTitle: Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11., conditionsModule conditions: Diabetic Peripheral Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blinded with regard to the study treatment that subjects receive,without the investigator, the sponsor, or the subjects being aware of wether YJ001 or the placebo is administered. All decisions concerning dose escalation will be made in a blinded manner by the safety review committee.The Safety Review Committee (SRC), comprised of the Principal Investigator, Medical Monitor, and Sponsor's qualified designee, will convene after completion of each cohort to evaluate available safety, PK, and other relevant data.The SRC will determine whether to proceed to the next planned dose level, continue with the study and add additional safety evaluations, expand the number of subjects at the current level, reduce the dose, or stop the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: YJ001 for Spray Use, interventions name: Placebo of YJ001 for Spray Use, outcomesModule primaryOutcomes measure: Safety Assessments - AEs, primaryOutcomes measure: Safety Assessments -Number of Participants With Abnormal Laboratory Values, primaryOutcomes measure: Safety Assessments - Skin Reaction, secondaryOutcomes measure: Pharmacokinetics-AUC, secondaryOutcomes measure: Pharmacokinetics- Cmax, secondaryOutcomes measure: Pharmacokinetics - tmax, secondaryOutcomes measure: Pharmacokinetics - tlag, secondaryOutcomes measure: Pharmacokinetics - t1/2, secondaryOutcomes measure: Pharmacokinetics - CLr/f,ss, secondaryOutcomes measure: Efficacy evaluation indicator, secondaryOutcomes measure: Efficacy evaluation indicators - ADSIS, secondaryOutcomes measure: Efficacy evaluation indicators - SF-MPQ, secondaryOutcomes measure: Efficacy evaluation indicators - VPT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trials of Texas,LLC, city: Fredericksburg, state: Texas, zip: 78229, country: United States, contacts name: Douglas Scott Denham, role: CONTACT, phone: 210-949-0122, geoPoint lat: 30.2752, lon: -98.87198, hasResults: False