Clinical Trials List
Protocol NumberPS1-01
Active
2023-09-01 - 2027-12-31
Phase I
Recruiting1
ICD-10E11.65
Type 2 diabetes mellitus with hyperglycemia
ICD-10E11.69
Type 2 diabetes mellitus with other specified complication
ICD-9250.82
Diabetes with other specified manifestations, Type II [non-insulin dependent type][NIDDM type][adult-onset type] or unspecified type, uncontrolled
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 Human
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
Pharmasaga Co., Ltd.
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Trial scale
Taiwan Single Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
MING-CHE LIU
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
PS1
Objectives
Primary Objective:
To evaluate the safety and tolerability of single and multiple oral
administration of PS1.
Secondary Objectives:
To evaluate the safety and pharmacokinetics (PK) of single and
multiple oral administration of PS1
To evaluate the food effect on single oral administration of PS1
To evaluate the potential efficacy of PS1 in T2DM patients
Exploratory Objectives:
To evaluate the effect of multiple oral administration of PS1 in
PDIA4
Test Drug
tablet
Active Ingredient
PS1 (4, 5-dimethoxy-2-propiolamidobenzoic acid)
Dosage Form
110
Dosage
25mg
Endpoints
Incidence of dose-limiting toxicity (DLT) during the DLT
observation period and the maximum tolerated dose (MTD) of PS1
observation period and the maximum tolerated dose (MTD) of PS1
Inclution Criteria
A subject is eligible for the study if all of the following apply:
1. Both genders aged 18 to 80 years, inclusive at screening
2. Body mass index (BMI) between 18.5 and 40.0 kg/m2
3. Negative test for hepatitis B surface antigen (HBsAg), Anti-
HCV antibody, and human immunodeficiency virus (HIV) at
screening. Subjects with positive anti-HCV may be enrolled
only if they have a negative HCV RNA result during the
screening period.
4. Is willing to follow the trial life style instruction and protocol
procedure
5. Able to understand and sign the informed consent form
Inclusion criteria applied for healthy subjects (Cohorts 1~4)
6. Overtly healthy subject, who is considered to be generally
healthy based on medical history, vital signs, laboratory tests,
1. Both genders aged 18 to 80 years, inclusive at screening
2. Body mass index (BMI) between 18.5 and 40.0 kg/m2
3. Negative test for hepatitis B surface antigen (HBsAg), Anti-
HCV antibody, and human immunodeficiency virus (HIV) at
screening. Subjects with positive anti-HCV may be enrolled
only if they have a negative HCV RNA result during the
screening period.
4. Is willing to follow the trial life style instruction and protocol
procedure
5. Able to understand and sign the informed consent form
Inclusion criteria applied for healthy subjects (Cohorts 1~4)
6. Overtly healthy subject, who is considered to be generally
healthy based on medical history, vital signs, laboratory tests,
Exclusion Criteria
Any subject meeting any of the following exclusion criteria will be
excluded from study participation.
1. History of Type I diabetes mellitus
2. 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
3. Received strong CYP enzyme inhibitor or inducer within 14
days before Screening
4. Received any vaccination within 14 days before Screening
5. Has required insulin therapy within the past 12 weeks
6. Known hypersensitivity to any of the components of PS1 tablet
7. 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—other than T2DM and its
excluded from study participation.
1. History of Type I diabetes mellitus
2. 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
3. Received strong CYP enzyme inhibitor or inducer within 14
days before Screening
4. Received any vaccination within 14 days before Screening
5. Has required insulin therapy within the past 12 weeks
6. Known hypersensitivity to any of the components of PS1 tablet
7. 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—other than T2DM and its
The Estimated Number of Participants
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Taiwan
75 participants
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Global
75 participants
