nctId: NCT06334211 id: FP-020C-23-001 briefTitle: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-09-30 date: 2025-01-31 date: 2024-03-27 date: 2024-04-11 name: Foresee Pharmaceuticals Co., Ltd. class: INDUSTRY name: InClin, Inc. 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. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 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 masking: TRIPLE maskingDescription: Double-blind (placebo appears the same as active FP-020) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: FP-020 name: placebo measure: The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs). measure: Clinically significant abnormalities. measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2 measure: Evaluate the food effect on the PK profile of FP-020 - Cmax measure: Evaluate the food effect on the PK profile of FP-020 - Tmax measure: Evaluate the food effect on the PK profile of FP-020 - AUC measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24 measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2 measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Scientia Clinical Research Ltd city: Randwick state: New South Wales zip: 2031 country: Australia name: Christopher Argent, MD role: CONTACT lat: -33.91439 lon: 151.24895 hasResults: False