Evaluating a new medication for blood glucose control in type II diabetes

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 study is testing a new medication called PS1 to see if it can help people with type II diabetes control their blood sugar better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Pharmasaga Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT05176210 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and food effects of a new medication called PS1 in subjects with type II diabetes and healthy volunteers. The study employs a randomized, double-blind, placebo-controlled design, consisting of single ascending doses, food effect assessments, and multiple ascending doses. Participants will receive either PS1 or a placebo in various cohorts, with follow-up periods to monitor their health and response to the medication. The trial aims to gather crucial data on the potential efficacy of PS1 for managing blood glucose levels.

Who should consider this trial

Good fit: Ideal candidates for this study include adults aged 18 to 80 with type II diabetes or healthy individuals meeting specific health criteria.

Not a fit: Patients with uncontrolled diabetes or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new effective treatment option for patients with type II diabetes.

How similar studies have performed: Other studies have shown promise with similar approaches in developing new diabetes medications, but this specific intervention is novel.

Eligibility criteria

Inclusion Criteria:

For all cohorts, 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
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\~6)
6. 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
7. With HbA1c value of \< 6.5% and fasting plasma glucose \< 110 mg/dL at Screening
8. With estimated glomerular filtration rate (eGFR) \> 80 ml/min

   Inclusion criteria applied for T2DM patients (Cohort 7 and 8)
9. Diagnosis of T2DM
10. T2DM treated with diet and exercise alone currently, for at least 2 weeks prior to Screening
11. With HbA1c level between 6.5% to 9.0% and fasting plasma glucose level between 130 mg/dL to 250 mg/dL at Screening
12. With estimated glomerular filtration rate (eGFR) \> 60 ml/min
13. 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

Exclusion Criteria:

For all cohorts, a 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
8. History of pancreatitis
9. Serum amylase \> 1.5 × Upper Limit of Normal (ULN) or lipase \> 1.5 × ULN
10. Clinically significant ECG abnormality at Screening
11. History of cancer (malignancy) or have ever received any anti-cancer therapy
12. Regular smoker Regular smoker is defined as who smokes every day (≥ 1 cigarette/day in average in the past 8 weeks of Screening)
13. 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)
14. Received any investigational therapy from another clinical study or underwent any major surgeries within the last 12 weeks prior to Screening.
15. Took glucose-lowering medications within the last 2 weeks prior to Screening
16. Received any systemic steroids (inhaled and intranasal steroids are permitted) or other immunosuppressive medications within 4 weeks prior to Screening
17. Have ever received cell therapy or organ transplantation
18. Other conditions not suitable for participating in this study as judged by the investigator
19. Any conditions that forbid the completion of study procedures due to the local regulatory restrictions
20. Female subject of childbearing potential who:

    * Is lactating; or
    * Has a positive pregnancy test result at Screening; or
    * Refuses to adopt at least one form of birth control (refer to Section 5.3) from signing informed consent to the end of the study.
21. Male subject with a female spouse/partner who is of childbearing potential refuses to adopt at least one form of birth control (refer to Section 5.3) from signing informed consent to the end of the study.

    Exclusion criteria applied for healthy subjects (Cohorts 1\~6):
22. History of type II diabetes mellitus

Where this trial is running

Taipei

• Mingche Liu — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Mingche Liu, MD., PhD — Taipei Medical University Hospital
• Study coordinator: Yuyu Chung, Master

Conditions Type II Diabetes