AdipoPharma LLC
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 sign…
A drug targeting the interaction between the ALMS1 protein and alpha-PKC
Excipient only formulation, without active compound