A Study of PATAS Using Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Diabetic Subjects
Eligible age
18–65 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: AdipoPharma LLC
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ <!-- -->
- ✕ 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 \</= 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening or at Check-In (Day -1);
- ✕ 4. Thyroid-stimulating hormone (TSH) outside of reference range (e.g., TSH \<1 × lower limit of normal \[LLN\] or TSH \>1 × ULN) at Screening; Note: Abnormal TSH results will reflex to a free thyroxine (T4) test.
- ✕ 5. History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease;
- ✕ 6. Personal or family history of long QT syndrome;
- ✕ 7. Clinically significant history of any disease or disorder (i.e., gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic) deemed to be exclusionary, as judged by the Investigator;
Where it's recruiting
Source: ClinicalTrials.gov · NCT07223333 · last updated 2026-09-29