protocolSection identificationModule nctId: NCT06359600, orgStudyIdInfo id: HS-10501-101, briefTitle: A Study of HS-10501 Tablets in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: HS-10501 tablet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events(AE), serious AEs and AE leading to withdrawal from treatment., primaryOutcomes measure: Number of participants with clinically significant abnormalities in lab tests, primaryOutcomes measure: Number of participants with clinically significant change from baseline in vital signs, primaryOutcomes measure: Change from baseline in Electrocardiogram (ECG), secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-t, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - Cmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - Tmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - t1/2, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - CL/F, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501- Vz/F, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501-λz, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501- AUC0-τ, secondaryOutcomes measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT), secondaryOutcomes measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT), secondaryOutcomes measure: body weight changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The second hospital of Anhui University, status: RECRUITING, city: Hefei, state: Anhui, zip: 230601, country: China, contacts name: Wei Hu, MD, role: CONTACT, phone: 13856086475, email: ayefygcp@163.com, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False