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
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedStudy Start
First participant enrolled
December 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedApril 15, 2024
April 1, 2024
1.5 years
November 29, 2021
April 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of dose-limiting toxicity (DLT) during the DLT observation period
DLT is defined as: (1) any adverse event (AE) ≥ Grade 3 (CTCAE v5.0) or (2) Grade 2 AE that does not resolve to grade 1 or less within 72 hours, that occurs in the DLT observation period and is causally related (possibly, probably, or definitely related) to the test article judged by the investigator.
Day 1~ Day 8 (SAD cohort); Day 1~ Day 35 (MAD cohort)
Secondary Outcomes (16)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
SAD, FE: up to 4 weeks; MAD: up to 8 weeks
Number of participants with abnormalities in Vital signs
SAD, FE: Baseline,1~2 weeks; MAD: Baseline,1~6 weeks
Number of participants with abnormalities in Laboratory examinations
SAD, FE: Baseline,1~2 weeks; MAD: Baseline,1~6 weeks
Acute kidney injury (AKI) marker
SAD, FE: Baseline, 1~2 weeks; MAD: Baseline, 1~6 weeks
Number of participants with abnormalities in 12-lead electrocardiogram (EKG)
SAD, FE: Baseline, 1~2 weeks; MAD: Baseline, 1~6 weeks
- +11 more secondary outcomes
Study Arms (8)
SAD portion - Cohort 1 (25mg)
EXPERIMENTALAn eligible subject will receive a single dose of 25 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
SAD portion - Cohort 2 (50mg)
EXPERIMENTALAn eligible subject will receive a single dose of 50 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
SAD portion - Cohort 3 (75mg)
EXPERIMENTALAn eligible subject will receive a single dose of 75 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
FE portion - Cohort 4 (50mg)
EXPERIMENTALAn eligible subject 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.
MAD portion - Cohort 5 (25mg)
EXPERIMENTALAn eligible subject will receive 25 mg PS1 or Placebo tablets once daily in a fed condition for 14 days and be followed for additional 7 days.
MAD portion - Cohort 6 (50mg)
EXPERIMENTALAn eligible subject will receive 50 mg PS1 or Placebo tablets once daily in a fed condition for 14 days and be followed for additional 7 days.
MAD portion - Cohort 7 (25mg)
EXPERIMENTALAn eligible subject will receive 25 mg PS1 or Placebo tablets once daily in a fed condition for 28 days and be followed for additional 7 days.
MAD portion - Cohort 8 (50mg)
EXPERIMENTALAn eligible subject will receive 50 mg PS1 or Placebo tablets once daily in a fed condition for 28 days and be followed for additional 7 days.
Interventions
PS1 will be provided as a 120 mg tablet with 25 mg active pharmaceutical ingredient.
Placebo will be provided as a 120 mg tablet.
Eligibility Criteria
You may qualify if:
- For all cohorts, a subject is eligible for the study if all of the following apply:
- Both genders aged 18 to 80 years, inclusive at screening
- Body mass index (BMI) between 18.5 and 40.0 kg/m2
- Negative test for hepatitis B surface antigen (HBsAg), Anti-HCV antibody, and human immunodeficiency virus (HIV) at screening
- Is willing to follow the trial life style instruction and protocol procedure
- Able to understand and sign the informed consent form.
- Overtly healthy subject, who is considered to be generally healthy based on medical history, vital signs, laboratory tests, 12-lead EKG, and physical examination, as judged by the investigator
- With HbA1c value of \< 6.5% and fasting plasma glucose \< 110 mg/dL at Screening
- With estimated glomerular filtration rate (eGFR) \> 80 ml/min
- Diagnosis of T2DM
- T2DM treated with diet and exercise alone currently, for at least 2 weeks prior to Screening
- With HbA1c level between 6.5% to 9.0% and fasting plasma glucose level between 130 mg/dL to 250 mg/dL at Screening
- With estimated glomerular filtration rate (eGFR) \> 60 ml/min
- For patients taking medication for other chronic disease, the medication should be on a stable dose for at least 4 weeks prior to Screening, and should not be a strong CYP enzyme inhibitor or inducer
You may not qualify if:
- History of Type I diabetes mellitus
- Under the systemic treatment of any prescription medication or over-the-counter (OTC) medication that may interfere with the safety or PK assessment judged by the investigator within 7 days before Screening
- Received strong CYP enzyme inhibitor or inducer within 14 days before Screening
- Received any vaccination within 14 days before Screening
- Has required insulin therapy within the past 12 weeks
- Known hypersensitivity to any of the components of PS1 tablet
- History of major clinically significant hematological, renal, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, immune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within 3 months of Screening that may significantly alter the biomarker panel, require receiving any systemic medications, or interfere with the interpretation of data, as judged by the investigator
- History of pancreatitis
- Serum amylase \> 1.5 × Upper Limit of Normal (ULN) or lipase \> 1.5 × ULN
- Clinically significant ECG abnormality at Screening
- History of cancer (malignancy) or have ever received any anti-cancer therapy
- Regular smoker Regular smoker is defined as who smokes every day (≥ 1 cigarette/day in average in the past 8 weeks of Screening)
- Consumed greater than 3 units of alcoholic beverages per day in average for the past 4 weeks before Screening One unit is equivalent to one can of beer (20% alcohol; about 45 mL)
- Received any investigational therapy from another clinical study or underwent any major surgeries within the last 12 weeks prior to Screening.
- Took glucose-lowering medications within the last 2 weeks prior to Screening
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mingche Liu
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingche Liu, MD., PhD
Taipei Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
January 4, 2022
Study Start
December 22, 2023
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
April 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share