protocolSection identificationModule nctId: NCT06385158, orgStudyIdInfo id: GenSci074-101, briefTitle: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Changchun GeneScience Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population, conditionsModule conditions: Vasomotor System; Labile, conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: GS1-144 tablet, outcomesModule primaryOutcomes measure: Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)., primaryOutcomes measure: Part 3: Number of Participants With TEAEs and SAEs, secondaryOutcomes measure: Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144, secondaryOutcomes measure: Part 1, Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144, secondaryOutcomes measure: Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144, secondaryOutcomes measure: Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144, secondaryOutcomes measure: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144, secondaryOutcomes measure: Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144, secondaryOutcomes measure: Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144, secondaryOutcomes measure: Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144, secondaryOutcomes measure: Part 3: Accumulation Ratio for GS1-144, secondaryOutcomes measure: Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huashan Hospital, Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False