Type II DiabetesPhase 1NCT05176210
Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects
A Phase 1 study testing PS1 in people with Type II Diabetes, run by Pharmasaga Co. Ltd. at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- PS1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Dec 2023to 5 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. Subjects with positive anti-HCV may be enrolled only if they have a negative HCV RNA result during the screening period.
- Is willing to follow the trial life style instruction and protocol procedure
- Able to understand and sign the informed consent form
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- Inclusion criteria applied for healthy subjects (Cohorts 1~4)
- 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/1.73m2
- Inclusion criteria applied for T2DM patients (Cohorts A, B, 7, and 8)
- Diagnosis of T2DM
- T2DM treated with diet and exercise alone currently, for at least 2 weeks prior to Screening
- With HbA1c level between 5.7% to 9.0% or fasting plasma glucose level between 100 mg/dL to 250 mg/dL at Screening
- With estimated glomerular filtration rate (eGFR) > 60 ml/min /1.73m2
- Patients taking medications for T2DM comorbidities, i.e., hypertriglyceridemia, hyperlipidemia, and hypertension, should be on a stable dose of their medication for at least 3 months prior to Screening. Any other chronic medications should be on a stable dose for at least 4 weeks prior to Screening.
Who cannot join
- Any subject meeting any of the following exclusion criteria will be excluded from study participation.
- 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
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- 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-other than T2DM and its comorbidities (i.e., hypertriglyceridemia, hyperlipidemia, and hypertension)
- 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 (<10% alcohol; about 330 mL), one glass of wine (10~20% alcohol; about 150 mL), or one shot of distilled spirits (>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
- Received any systemic steroids (inhaled and intranasal steroids are permitted) or other immunosuppressive medications within 4 weeks prior to Screening
- Have ever received cell therapy or organ transplantation
- Other conditions not suitable for participating in this study as judged by the investigator
- Any conditions that forbid the completion of study procedures due to the local regulatory restrictions
- Female subject of childbearing potential who:
- Is lactating; or
- Has a positive pregnancy test result at Screening; or
- Refuses abstinence or to adopt at least two forms of highly effective contraception from signing informed consent to the end of the study.
- Male subject with a female spouse/partner who is of childbearing potential refuses abstinence or to adopt at least two forms of highly effective contraception from signing informed consent to the end of the study.
- Exclusion criteria applied for healthy subjects (Cohorts 1~4):
- History of type II diabetes mellitus
- Exclusion criteria applied for T2DM patients (Cohorts 7 and 8):
- Triglyceride >300 mg/dL (fasting lipid profile) or cholesterol > 1.5 × ULN (fasting lipid profile)
- Received beta-blockers, angiotensin receptor-neprilysin inhibitors (ARNI; e.g., Entresto (sacubitril/valsartan)), or renin inhibitors (e.g., Rasilez (aliskiren)) medications within 3 months prior to Screening
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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 for healthy subjects with three SAD dose cohorts-25 mg (Cohort 1), 50 mg (Cohort 2), and 75 mg (Cohort 3). An eligible subject will receive a single dose of PS1 or Placebo tablets (8 subjects in each cohort, 6 PS1 + 2 Placebo) 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 (randomized, double-blinded, placebo-controlled, 6 PS1 + 2 Placebo) as the SAD cohorts. An 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.
SAD portion for T2DM patients: An open-labeled study design will be applied for the SAD portion for T2DM patients with two SAD dose cohorts-25 mg (Cohort A) and 50 mg (Cohort B). An eligible T2DM patients will receive a single dose of PS1 tablets (6 subjects in each cohort) in a fed condition on Day 1 and be followed for 14 days. Subjects in this portion will have safety and PK observation but will not be evaluated for DLT.
MAD portion for T2DM patients: After confirming the safety and pharmacokinetics of all SAD cohorts (Cohorts 1, 2, 3, A, and B) and the FE cohort (Cohort 4) by iSMC and approved by the authority, a randomized, double-blinded, placebo-controlled study design will be applied for the MAD portion for T2DM patients with two MAD dose cohorts-25 mg/day (Cohort 7) and 50 mg/day (Cohort 8). An eligible subject will receive PS1 or Placebo (8 subjects in each cohort, in a 6:2 ratio of PS1: Placebo) tablets once daily in a fed condition. The treatment period is 28±1 days. All subjects will be followed for additional 7 days.
- Conditions
- Type II Diabetes
- Being tested
- PS1, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS1Drug
PS1 will be provided as a 120 mg tablet with 25 mg active pharmaceutical ingredient.
PlaceboDrug
Placebo will be provided as a 120 mg tablet.
| Study group | Role | What they receive |
|---|---|---|
| SAD portion - Cohort 1 (25mg) | Experimental | An eligible healthy subject will receive a single dose of 25 mg of PS1 or Placebo tablet in a fed condition on Day 1 and be followed for 7 days. Receives: Drug: PS1; Drug: Placebo |
| SAD portion - Cohort 2 (50mg) | Experimental | An eligible healthy 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. Receives: Drug: PS1; Drug: Placebo |
| SAD portion - Cohort 3 (75mg) | Experimental | An eligible healthy 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. Receives: Drug: PS1; Drug: Placebo |
| FE portion - Cohort 4 (50mg) | Experimental | An eligible healthy 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. Receives: Drug: PS1; Drug: Placebo |
| SAD portion - Cohort A (25mg) | Experimental | An eligible T2DM subject will receive 25 mg PS1 tablet once daily in a fed condition for 1 day and be followed for additional 14 days. Receives: Drug: PS1; Drug: Placebo |
| SAD portion - Cohort B (50mg) | Experimental | An eligible T2DM subject will receive 50 mg PS1 tablets once daily in a fed condition for 1 day and be followed for additional 14 days. Receives: Drug: PS1; Drug: Placebo |
| MAD portion - Cohort 7 (25mg) | Experimental | An eligible subject will receive 25 mg PS1 or Placebo tablet once daily in a fed condition for 28±1 days and be followed for additional 7 days. Receives: Drug: PS1; Drug: Placebo |
| MAD portion - Cohort 8 (50mg) | Experimental | An eligible subject will receive 50 mg PS1 or Placebo tablets once daily in a fed condition for 28±1 days and be followed for additional 7 days. Receives: Drug: PS1; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) during the DLT observation period and the maximum tolerated dose (MTD) of PS1
Dose escalation will be terminated based on the following criteria:
- Among the six subjects who received PS1 in a cohort, more than one subject experienced DLT(s). MTD will basically be declared as the highest dose level at which ≤1/6 of PS1-treated subjects in a cohort experienced DLT(s).
DLT is defined as
- any adverse event (AE) ≥ Grade 3 (CTCAE v5.0)* or
- Grade 2 AE that does not resolve to grade 1 or less within 3 days* * Note: For Cohorts 7 and 8, AEs requiring specific definitions will be referenced under the heading 'For MAD cohorts (Cohorts 7 and 8)' below, while the remaining AEs will be followed the standard procedures outlined herein. that occurs in the DLT observation period and is causally related (possibly, probably, or definitely related) to the test article judged by the investigator.
Measured: DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1
Secondary outcomes (30)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
All adverse events (AEs) will be assessed for severity by the investigator based on NCI-CTCAE v5.0
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Systolic Blood Pressure & Diastolic Blood Pressure) at each post-treatment measurement from baseline
Vital signs (Systolic Blood Pressure \& Diastolic Blood Pressure)(Unit: mmHg)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) (Unit: g/dL)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in acute kidney injury (AKI)-NGAL markers at each post-treatment measurement from baseline
Urine samples will be collected for analyzing acute kidney injury (AKI) markers, NGAL.
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in 12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval) at each post-treatment measurement from baseline
PR interval, QRS interval, and QT interval will be recorded. [Unit: msec]
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Abnormalities in Physical examination
Number of participants with abnormal Physical examination findings, including general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Pharmacokinetics (PK) of PS1
AUC_Area under the serum concentration-time profile
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Cmax_The peak post-dose concentration
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Tmax_Time at which Cmax is observed
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
T1/2_Terminal phase elimination half-life
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
MRT_Mean Residence Time
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
CL/F_Apparent Clearance
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Volume of distribution
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Rac_Accumulation ratio
Measured: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Potential efficacy (For Cohort 7 and 8 only)
Changes from baseline of fasting plasma glucose (FPG) at each post-treatment visit; Changes from baseline of C-peptide at each post-treatment visit; Changes from baseline of hemoglobin A1c (HbA1c) at Visit 10 and Visit 11.
Measured: MAD in T2DM subjects: Approximately 7 weeks
Changes from baseline of postprandial plasma glucose (PPG), at each post-treatment visit in T2DM patients
Postprandial plasma glucose (PPG) data.
Measured: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes from baseline of postprandial serum insulin (PSI) at each post-treatment visit in T2DM patients
Postprandial serum insulin (PSI) data.
Measured: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes from baseline of fasting serum insulin (FSI) at each post-treatment visit in T2DM patients
Fasting serum insulin (FSI) data.
Measured: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in acute kidney injury (AKI)-KIM-1 markers at each post-treatment measurement from baseline
Urine samples will be collected for analyzing acute kidney injury (AKI) markers, KIM-1.
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Biochemistry at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Biochemistry physiological parameter tests results
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Urinalysis at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Urinalysis physiological parameter tests results
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Pulse rate) at each post-treatment measurement from baseline
Vital signs (Pulse rate) (Unit: beats/min)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Respiratory Rate) at each post-treatment measurement from baseline
Vital signs (Respiratory Rate) (Unit: breaths/min)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Temperature) at each post-treatment measurement from baseline
Vital signs (Temperature) (Unit: Celsius)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) (Unit: %)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (RBC) at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (RBC) (Unit: 10^6/uL)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (platelet and WBC) at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (platelet and WBC) (Unit: 10^3/uL)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (mean corpuscular volume, MCV) at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular volume, MCV) (Unit: fL)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (mean corpuscular hemoglobin, MCH) at each post-treatment measurement from baseline
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular hemoglobin, MCH) (Unit: pg)
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in 12-lead electrocardiogram (EKG) (Ventricular rate) at each post-treatment measurement from baseline
Ventricular rate will be recorded. [Unit: beats/min]
Measured: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start22 Dec 2023
- Primary completion27 Apr 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- An "open-labeled" study design will be applied for the SAD portion for T2DM patients with two SAD dose cohorts-25 mg (Cohort A) and 50 mg (Cohort B).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasaga Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingche Liu, MD., PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176210
- Sponsor's protocol ID
- PS1-01
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05176210
- Acronym / sponsor ID
- PS1-01
- Conditions
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Pharmasaga Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 for healthy subjects with three SAD dose cohorts-25 mg (Cohort 1), 50 mg (Cohort 2), and 75 mg (Cohort 3). An eligible subject will receive a single dose of PS1 or Placebo tablets (8 subjects in each cohort, 6 PS1 + 2 Placebo) 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 (randomized, double-blinded, placebo-controlled, 6 PS1 + 2 Placebo) as the SAD cohorts. An 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.
SAD portion for T2DM patients: An open-labeled study design will be applied for the SAD portion for T2DM patients with two SAD dose cohorts-25 mg (Cohort A) and 50 mg (Cohort B). An eligible T2DM patients will receive a single dose of PS1 tablets (6 subjects in each cohort) in a fed condition on Day 1 and be followed for 14 days. Subjects in this portion will have safety and PK observation but will not be evaluated for DLT.
MAD portion for T2DM patients: After confirming the safety and pharmacokinetics of all SAD cohorts (Cohorts 1, 2, 3, A, and B) and the FE cohort (Cohort 4) by iSMC and approved by the authority, a randomized, double-blinded, placebo-controlled study design will be applied for the MAD portion for T2DM patients with two MAD dose cohorts-25 mg/day (Cohort 7) and 50 mg/day (Cohort 8). An eligible subject will receive PS1 or Placebo (8 subjects in each cohort, in a 6:2 ratio of PS1: Placebo) tablets once daily in a fed condition. The treatment period is 28±1 days. All subjects will be followed for additional 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- An "open-labeled" study design will be applied for the SAD portion for T2DM patients with two SAD dose cohorts-25 mg (Cohort A) and 50 mg (Cohort B).
| Arm | Type | Receives |
|---|---|---|
| SAD portion - Cohort 1 (25mg) | Experimental | Drug: PS1, Drug: PlaceboAn eligible healthy subject will receive a single dose of 25 mg of PS1 or Placebo tablet in a fed condition on Day 1 and be followed for 7 days. |
| SAD portion - Cohort 2 (50mg) | Experimental | Drug: PS1, Drug: PlaceboAn eligible healthy 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) | Experimental | Drug: PS1, Drug: PlaceboAn eligible healthy 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) | Experimental | Drug: PS1, Drug: PlaceboAn eligible healthy 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. |
| SAD portion - Cohort A (25mg) | Experimental | Drug: PS1, Drug: PlaceboAn eligible T2DM subject will receive 25 mg PS1 tablet once daily in a fed condition for 1 day and be followed for additional 14 days. |
| SAD portion - Cohort B (50mg) | Experimental | Drug: PS1, Drug: PlaceboAn eligible T2DM subject will receive 50 mg PS1 tablets once daily in a fed condition for 1 day and be followed for additional 14 days. |
| MAD portion - Cohort 7 (25mg) | Experimental | Drug: PS1, Drug: PlaceboAn eligible subject will receive 25 mg PS1 or Placebo tablet once daily in a fed condition for 28±1 days and be followed for additional 7 days. |
| MAD portion - Cohort 8 (50mg) | Experimental | Drug: PS1, Drug: PlaceboAn eligible subject will receive 50 mg PS1 or Placebo tablets once daily in a fed condition for 28±1 days and be followed for additional 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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. Subjects with positive anti-HCV may be enrolled only if they have a negative HCV RNA result during the screening period.
- Is willing to follow the trial life style instruction and protocol procedure
- Able to understand and sign the informed consent form
Key exclusion criteria (30 listed)
- Any subject meeting any of the following exclusion criteria will be excluded from study participation.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS1PS1 will be provided as a 120 mg tablet with 25 mg active pharmaceutical ingredient. | Drug | FE portion - Cohort 4 (50mg), MAD portion - Cohort 7 (25mg), MAD portion - Cohort 8 (50mg), SAD portion - Cohort 1 (25mg), SAD portion - Cohort 2 (50mg), SAD portion - Cohort 3 (75mg), SAD portion - Cohort A (25mg), SAD portion - Cohort B (50mg) |
| PlaceboPlacebo will be provided as a 120 mg tablet. | Drug | FE portion - Cohort 4 (50mg), MAD portion - Cohort 7 (25mg), MAD portion - Cohort 8 (50mg), SAD portion - Cohort 1 (25mg), SAD portion - Cohort 2 (50mg), SAD portion - Cohort 3 (75mg), SAD portion - Cohort A (25mg), SAD portion - Cohort B (50mg) |
Primary outcome
Incidence of dose-limiting toxicity (DLT) during the DLT observation period and the maximum tolerated dose (MTD) of PS1
Time frame: DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1
Dose escalation will be terminated based on the following criteria: - Among the six subjects who received PS1 in a cohort, more than one subject experienced DLT(s). MTD will basically be declared as the highest dose level at which ≤1/6 of PS1-treated subjects in a cohort experienced DLT(s). 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 3 days* * Note: For Cohorts 7 and 8, AEs requiring specific definitions will be referenced under the heading 'For MAD cohorts (Cohorts 7 and 8)' below, while the remaining AEs will be followed the standard procedures outlined herein. that occurs in the DLT observation period and is causally related (possibly, probably, or definitely related) to the test article judged by the investigator.
30 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Systolic Blood Pressure & Diastolic Blood Pressure) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in acute kidney injury (AKI)-NGAL markers at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in 12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Abnormalities in Physical examination
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Pharmacokinetics (PK) of PS1
Time frame: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
Potential efficacy (For Cohort 7 and 8 only)
Time frame: MAD in T2DM subjects: Approximately 7 weeks
Changes from baseline of postprandial plasma glucose (PPG), at each post-treatment visit in T2DM patients
Time frame: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes from baseline of postprandial serum insulin (PSI) at each post-treatment visit in T2DM patients
Time frame: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes from baseline of fasting serum insulin (FSI) at each post-treatment visit in T2DM patients
Time frame: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in acute kidney injury (AKI)-KIM-1 markers at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Biochemistry at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Urinalysis at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Pulse rate) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Respiratory Rate) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in vital signs (Temperature) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (RBC) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (platelet and WBC) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (mean corpuscular volume, MCV) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in Laboratory examinations - Hematology (mean corpuscular hemoglobin, MCH) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Changes in 12-lead electrocardiogram (EKG) (Ventricular rate) at each post-treatment measurement from baseline
Time frame: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingche Liu, MD., PhD principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PS1 in people with Type II Diabetes, run by Pharmasaga Co. Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) during the DLT observation period and the maximum tolerated dose (MTD) of PS1 (time frame: DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.