NCT05176210

Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects

A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect and Potential Efficacy of PS1 in Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Pharmasaga Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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), food effect and potential efficacy of PS1 in subjects.

Detailed description

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, food effect and potential efficacy 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-25 mg (Cohort 1), 50 mg (Cohort 2), and 75 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 7 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 50 mg PS1 or Placebo tablets in a fasted condition on Day 1 and be followed for 7 days. Four cohorts are assigned in the MAD portion: 25 mg/day (Cohort 5 \& 7) and 50 mg/day (Cohort 6 \& 8) in healthy volunteers and participants respectively. Only the dose level of MAD lower than the maximum tolerated dose (MTD) of SAD portion can be activated (If 50 mg was determined as the MTD of SAD, only cohort 5 \& 7 could be activated). An eligible subject will receive PS1 or Placebo tablets once daily in a fed condition for 14 days \& 28 days in healthy volunteers and participants respectively and be followed for additional 7 days.

Conditions

• Type II Diabetes

Interventions

Type	Name	Description
DRUG	PS1	PS1 will be provided as a 120 mg tablet with 25 mg active pharmaceutical ingredient.
DRUG	Placebo	Placebo will be provided as a 120 mg tablet.

Timeline

• Start date: 2023-12-22
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-01-04
• Last updated: 2024-04-15

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study