Safety, Pharmacokinetics, and Food Effect of PS1 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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), and food effect of PS1 in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmasaga Co. Ltd.

Criteria

Inclusion Criteria:

• Both genders aged 20 to 80 years, inclusive at screening

• 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% at Screening

• Fasting plasma glucose < 110 mg/dL at Screening

• Body mass index (BMI) between 18.5 and 28.0 kg/m2

• Negative test for hepatitis B surface antigen (HBsAg), Anti-HCV antibody, or human immunodeficiency virus (HIV) at screening

• Is willing to comply with the trial restrictions

• Able to understand and sign the informed consent form

Exclusion Criteria:

• History of diabetes mellitus

• Under the systemic treatment of any prescription medication or over-the-counter (OTC) medication within 7 days before Screening

• Received any vaccination within 14 days before Screening

• Known hypersensitivity to any of the components of PS1 tablet

• History of clinically significant hematological, renal, endocrine, pulmonary, 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 cancer (malignancy) or have ever received any anti-cancer therapy

• Regular smoker

• Consumed greater than 3 glasses of alcoholic beverages per day for the past 4 weeks before Screening

• Received any investigational therapy from another clinical study, performed any major surgeries, or took glucose-lowering medications within the last 12 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 from signing informed consent to the end of the study; 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.

• 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.