This first-in-human Phase I study consists of a single ascending-dose (SAD) portion, a food effect (FE) portion, and a multiple ascending-dose (MAD) portion, aiming to evaluate the safety, tolerability, pharmacokinetics, and food effect of PS1 in healthy subjects.~A randomized, double-blinded, placebo-controlled study design will be applied for the SAD portion with three SAD dose cohorts-100 mg (Cohort 1), 200 mg (Cohort 2), and 400 mg (Cohort 3). An eligible subject in this portion will receive a single dose of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 14 days.~In FE portion, only one cohort (Cohort 4) is assigned. The FE cohort (Cohort 4) will use the same study design as the SAD cohorts. An eligible subject in this portion will receive a single dose of 100 mg PS1 or Placebo tablets in a fasted condition on Day 1 and be followed for 14 days.~Two cohorts are assigned in the MAD portion: 50 mg/day (Cohort 5) and 100 mg/day (Cohort 6). Only the dose level of MAD lower than the maximum tolerated dose (MTD) of SAD portion can be activated (If 100 mg was determined as the MTD of SAD, only cohort 5 could be activated). An eligible subject will receive PS1 or Placebo tablets once daily in a fed condition for 28 days and be followed for additional 14 days.
This is a phase I, double-blind, placebo-controlled, randomized, single- and multiple-ascending dose study to evaluate new study intervention, PS1. PS1 is a potential blood glucose control medication, which is developed by Pharmasaga Co. Ltd. planned for treating type II diabetes mellitus (T2DM). This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of PS1 in healthy subjects.