Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects

Launched by PHARMASAGA CO. LTD. · Jan 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called PS1, which is being developed to help control blood sugar levels in people with Type II diabetes. It is a phase 1 study, meaning it is the first time this medication is being tested in humans. The researchers want to find out how safe PS1 is, how it is processed in the body, how food might affect its effectiveness, and whether it could help manage diabetes symptoms.

To join this trial, participants need to be between 18 and 80 years old, have a body weight within a certain range, and meet specific health criteria. For example, individuals with Type II diabetes should have blood sugar levels between 130 and 250 mg/dL. Participants will be closely monitored throughout the study, and they will follow specific guidelines to ensure their safety. It's important to note that anyone with a history of certain health issues or who is currently on specific medications may not be eligible to participate.

Gender

ALL

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