protocolSection identificationModule nctId: NCT06334211, orgStudyIdInfo id: FP-020C-23-001, briefTitle: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Foresee Pharmaceuticals Co., Ltd., class: INDUSTRY, collaborators name: InClin, Inc., descriptionModule briefSummary: This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FP-020 in Healthy Volunteers, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double-blind (placebo appears the same as active FP-020), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: FP-020, interventions name: placebo, outcomesModule primaryOutcomes measure: The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs)., primaryOutcomes measure: Clinically significant abnormalities., secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2, secondaryOutcomes measure: Evaluate the food effect on the PK profile of FP-020 - Cmax, secondaryOutcomes measure: Evaluate the food effect on the PK profile of FP-020 - Tmax, secondaryOutcomes measure: Evaluate the food effect on the PK profile of FP-020 - AUC, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Scientia Clinical Research Ltd, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: Christopher Argent, MD, role: CONTACT, geoPoint lat: -33.91439, lon: 151.24895, hasResults: False