A Study of PATAS Using Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Diabetic Subjects

This is 2-part study. The primary objective of Part 1 is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. Secondary objectives of Part 2 include evaluation of the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers and characterization of of adverse event (AE) profiles of the various dose levels of PATAS.

Inclusion Criteria: * Part 1: Single Ascending Dose Inclusion criteria 1. Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF); 2. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures; 3. Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening; 4. In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead electrocardiogram (ECG) at Screening and at Check-In (Day -1); 5. Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at Check-In (Day -1) (prior to the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug; 6. Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and 7. Willing to comply with all study procedures and requirements throughout the duration of the study. Exclusion Criteria: 1. Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary. 2. Liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], alkaline phosphatase \[ALP\], total bilirubin) outside the following upper limits of normal (ULNs) at Screening or at Check-In (Day -1): a. For ALT and AST, measurements \> ULN; b. For ALP, measurements \>ULN; or c. For total bilirubin, measurements \> ULN. 3. Estimated glomerular filtration rate \140 mmHg; or c. Diastolic BP \< 50 mmHg or \> 90 mmHg. 9. Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval \> 450 ms for males and \>470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion; 10. Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening; 11. Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives prior to first study drug administration, whichever is greater, or participation in \>3 clinical studies within 12 months; 22. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol); Part 2: Multiple Ascending Dose Inclusion Criteria 1. Male and female subjects, 18 to 65 years of age, inclusive, at the time of signing the ICF; 2. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures; 3. A diagnosis of T2D \>6 months before Screening 4. Subjects should be on a stable dose of 1. an oral monotherapy (permitted monotherapies include metformin and dipeptidyl peptidase 4 inhibitors) for at least 90 days before Screening 2. or a dual therapy (including metformin and dipeptidyl peptidase 4 inhibitors) for at least 6 months before Screening 3. or managing the condition through diet and exercise for at least 90 days before Screening; 5. Glycated hemoglobin 7 % and \3 clinical studies within 12 months; 30. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol); or 31. Employee of the Sponsor, the CRO, or the clinical site (e.g., permanent employee, temporary contract worker, or designee responsible for the conduct of the study) or family members (e.g., spouse, parent, sibling, or child) of the Sponsor, CRO, or other clinical site employee