Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects

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.

Timeline

Start

2023-12-22

Primary completion

2026-04-27

Completion

2026-06-05

Drugs

Indications