RecruitingPhase 1NCT05176210

Safety, Pharmacokinetics, and Food Effect of PS1 in Subjects

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

Sponsor

Pharmasaga Co. Ltd.

Enrollment

64 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

Type II Diabetes

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), food effect and potential efficacy of PS1 in subjects.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria14

For all cohorts, 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
Is willing to follow the trial life style instruction and protocol procedure
Able to understand and sign the informed consent form.
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
Diagnosis of T2DM
T2DM treated with diet and exercise alone currently, for at least 2 weeks prior to Screening
With HbA1c level between 6.5% to 9.0% and fasting plasma glucose level between 130 mg/dL to 250 mg/dL at Screening
With estimated glomerular filtration rate (eGFR) \> 60 ml/min
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 Criteria25

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
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
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 (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 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.
History of type II diabetes mellitus