RecruitingPhase 1NCT05176210

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

Sponsor

Pharmasaga Co. Ltd.

Enrollment

64 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

Type II Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety, how the body absorbs and processes a new drug called PS1, and whether food affects how the drug works. It includes both healthy people and people with Type 2 diabetes. **You may be eligible if:** - You are between 18 and 80 years old - Your BMI is between 18.5 and 40 - You do not have HIV, hepatitis B, or hepatitis C - If healthy: your blood sugar and kidney function are normal - If you have Type 2 diabetes: your blood sugar is managed by diet and exercise alone, your HbA1c (3-month blood sugar average) is between 6.5% and 9.0%, and your kidneys are functioning well **You may NOT be eligible if:** - You have active or recent serious illness - You are taking medications that strongly interact with certain liver enzymes (CYP inhibitors/inducers) - You are pregnant or nursing - You have uncontrolled or complex medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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