protocolSection identificationModule nctId: NCT06301074, orgStudyIdInfo id: HS-10509-101, briefTitle: The Phase I Study of HS-10509 in Chinese Adult Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia.Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: For each cohort, participants will be assigned to receive HS-10509 or placebo in parallel, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: HS-10509, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events(AE), serious AEs and AE leading to withdrawal from treatment., primaryOutcomes measure: Changes from baseline in lab tests, primaryOutcomes measure: Changes from baseline in vital signs, primaryOutcomes measure: Change from baseline in body weight, primaryOutcomes measure: Change from baseline in Electrocardiogram (ECG), primaryOutcomes measure: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS), primaryOutcomes measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS), primaryOutcomes measure: Change from baseline in Barnes Akathisia Rating Scale (BARS), primaryOutcomes measure: Change from baseline in Simpson-Angus Scale (SAS), secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: λz, secondaryOutcomes measure: t½, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vd/F, secondaryOutcomes measure: MRT, secondaryOutcomes measure: Css, max, secondaryOutcomes measure: Css, min, secondaryOutcomes measure: Css, av, secondaryOutcomes measure: Tss, max, secondaryOutcomes measure: AUCss, secondaryOutcomes measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, country: China, contacts name: Xiaojiao Li, Dr., role: CONTACT, phone: +86 13514314089, email: Xingxingsuo123456@126.com, geoPoint lat: 43.88, lon: 125.32278, hasResults: False