Clinical Trials Logo
  1. Home
  2. Type II Diabetes
  3. NCT05176210

Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects

Type II Diabetes Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05176210
Study type Interventional
Source Pharmasaga Co. Ltd.
Contact Yuyu Chung, Master
Phone +886-2-2793-8665
Email pm@pharmasaga.com
Status Recruiting
Phase Phase 1
Start date December 22, 2023
Completion date July 2025
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04569214 - The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients Phase 2
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT01698528 - Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration N/A
Completed NCT00985114 - Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity N/A
Active, not recruiting NCT05120219 - A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers Phase 1
Completed NCT04893135 - Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes N/A
Not yet recruiting NCT05108350 - A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects Phase 1
Completed NCT02586129 - Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes Phase 3
Completed NCT02914743 - Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes N/A
Completed NCT04540016 - Mass Balance and Biotransformation of [14C]HSK7653 in Human Phase 1
Completed NCT02429258 - Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin Phase 4
Completed NCT01055223 - Fracture Risk With Thiazolidinediones N/A
Terminated NCT02365233 - Fatty Liver Study in Patients With Type II Diabetes Phase 4
Completed NCT05878587 - Burger Allen Exercises in Knee OA With Type II Diabetes N/A
Completed NCT04768673 - A Study to Investigate the PK and Safety of CKD-393 Phase 1
Not yet recruiting NCT05028140 - Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus Phase 3
Terminated NCT01804777 - Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes Early Phase 1
Completed NCT01619332 - Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763 Phase 1/Phase 2
Not yet recruiting NCT01591525 - Diabetes Mellitus Community Based Screening in Minority Populations N/A
Completed NCT01881074 - Periodontal Treatment Response in Type II Diabetic Patients