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Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects

NCT05176210 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

  • Type II Diabetes

Interventions

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.

Sponsors & Collaborators

  • Pharmasaga Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Mingche Liu, MD., PhD · Taipei Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05176210 on ClinicalTrials.gov