A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
NCT Number: NCT06517914
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: YH35995|DRUG: Placebo
Sponsor: Yuhan Corporation
Sex: MALE
Age: ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2026-06
Locations: CHA Bundang Medical Center, Seongnam, Bundang-gu, 13496, Korea, Republic of

Summary:
This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995

Primary Outcome Measures: [Part A, B] Treatment-emergent adverse events (TEAEs), To assess the safety and tolerability of a single dose and multiple dose administration of YH35995, Part A: Day1-36, Part B: Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)
Secondary Outcome Measures: [Part A] Maximum observed plasma concentration (Cmax), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part A] Time to reach Cmax (Tmax), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part A] Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part A] AUC from time 0 to infinity (AUCinf), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part A] Apparent terminal elimination half-life (t1/2), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part A] Total plasma clearance (CL/F), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part A] Apparent volume of distribution (Vz/F), To characterize the pharmacokinetics (PK) of YH35995 and assess the food effect, Day1-36|[Part B] Cmax during the first dosing interval, To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Tmax during the first dosing interval, To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] AUC during the first dosing interval (AUClast), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] AUC during the dosing interval at steady state (AUCtau,ss), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Cmax at steady state (Cmax,ss), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Tmax at steady state (Tmax,ss), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Accumulation ratio using AUC (Rac(AUC)), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Accumulation ratio using Cmax (Rac(Cmax)), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Plasma concentration at the last observed time point during the dosing interval at steady state (Ctrough), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Average plasma concentration (Cavg), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Clearance at steady state (CLss/F), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Volume of distribution at steady state (Vss), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Effective half-life (t1/2,Rac), To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)|[Part B] Properly derived PD parameters for YH35995, including the area under the effect curve (AUEC) and maximum effect (Emax), To assess the pharmacodynamics(PD) of YH35995 after multiple dose administration, Day1-63(once daily dosing cohort), Day1-57(once weekly dosing cohort)