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.
‣ 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