protocolSection identificationModule nctId: NCT06308393, orgStudyIdInfo id: RSP61418, briefTitle: Randomized, Double-blind, Placebo-controlled Study of RSS0393 Ointment in Healthy and Psoriatic Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Randomized, double-blind, placebo-controlled study of RSS0393 ointment in healthy and psoriatic subjects, conditionsModule conditions: Healthy, conditions: Psoriatic Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: RSS0393 ointment；Placebo, outcomesModule primaryOutcomes measure: The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects）, primaryOutcomes measure: The percent of Local skin tolerance was assessed as moderate or higher （Multiple dose in healthy subjects）, primaryOutcomes measure: Measurement of blood examination（Multiple dose in patients ）, primaryOutcomes measure: Measurement of urine examination（Multiple dose in patients ）, primaryOutcomes measure: Measurement of Blood Chemistry examination（Multiple dose in patients ）, primaryOutcomes measure: Measurement of coagulation function examination（Multiple dose in patients ）, secondaryOutcomes measure: AUC0-t （Single dose in healthy subjects）, secondaryOutcomes measure: AUC0-∞（Single dose in healthy subjects）, secondaryOutcomes measure: Tmax（Single dose in healthy subjects）, secondaryOutcomes measure: Cmax（Single dose in healthy subjects）, secondaryOutcomes measure: t1/2（Single dose in healthy subjects）, secondaryOutcomes measure: CL/F（Single dose in healthy subjects）, secondaryOutcomes measure: Vz/F（Single dose in healthy subjects）, secondaryOutcomes measure: AUC0-t （Multiple dose in healthy subjects）, secondaryOutcomes measure: AUC0-∞（Multiple dose in healthy subjects）, secondaryOutcomes measure: Tmax（Multiple dose in healthy subjects）, secondaryOutcomes measure: Cmax（Multiple dose in healthy subjects）, secondaryOutcomes measure: t1/2（Multiple dose in healthy subjects）, secondaryOutcomes measure: CL/F（Multiple dose in healthy subjects）, secondaryOutcomes measure: Vz/F（Multiple dose in healthy subjects）, secondaryOutcomes measure: Absolute change in PASI score relative to baseline（Multiple dose in patients ）, secondaryOutcomes measure: The percentage change in PASI score relative to baseline（（Multiple dose in patients ）, secondaryOutcomes measure: The percentage of PASI50、PASI75、PASI90、PASI100（Multiple dose in patients ）, secondaryOutcomes measure: The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline （Multiple dose in patients ）, secondaryOutcomes measure: The percentage of subjects' inPGA score improvement ≥ 2 from baseline（Multiple dose in patients ）, secondaryOutcomes measure: Absolute change in BSA score relative to baseline（Multiple dose in patients ）, secondaryOutcomes measure: The percentage change in BSA score relative to baseline（Multiple dose in patients ）, secondaryOutcomes measure: Pharmacokinetics (PK) : Concentrations of RSS0393（Multiple dose in patients ）, secondaryOutcomes measure: Pharmacokinetics (PK) : The major metabolites of RSS0393（Multiple dose in patients ）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False