Single-ascending doses of PATAS Trifluoroacetate in healthy adults

First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study of Single Ascending Doses in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of PATAS

This will test single subcutaneous doses of PATAS Trifluoroacetate in healthy adults to see if the drug is safe and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AdipoPharma LLC (Industry-sponsored)
• Locations: 2 sites (Cincinnati, Ohio and 1 other locations)
• Trial ID: NCT07223333 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-ascending-dose study gives one subcutaneous dose of PATAS Trifluoroacetate to sequential cohorts of healthy adult volunteers to characterize safety, tolerability, and pharmacokinetics. A matching placebo arm is included for comparison. Doses are increased between cohorts only after review of safety data from earlier cohorts. Study procedures focus on clinical assessments, laboratory tests, ECGs, and blood sampling for PK measurements at a single center in Cincinnati, Ohio.

Who should consider this trial

Good fit: Healthy men and women aged 18 to 55 with a BMI of 20.0–35.0 kg/m2 who are not pregnant or lactating and meet screening health criteria are the intended participants.

Not a fit: People with diagnosed type 2 diabetes, uncontrolled medical conditions, or those who are pregnant or breastfeeding are unlikely to benefit from participation.

Why it matters

Potential benefit: If safe and well tolerated, PATAS could advance into later trials and potentially become a new option to improve insulin sensitivity for people with type 2 diabetes.

How similar studies have performed: Single-ascending-dose safety and PK studies are a standard early step in drug development and have supported later success for other diabetes drugs, but PATAS itself appears to be a novel investigational compound without prior clinical efficacy data.

Eligibility criteria

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 \</= 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;
8. Abnormal pulse rate or blood pressure (BP) measurements at Screening, defined as: a. Pulse rate \<40 bpm or \>100 bpm; b. Systolic BP \< 90 mmHg or \>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);

Where this trial is running

Cincinnati, Ohio and 1 other locations

• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States (Recruiting)
• Medpace Clinical Pharmaology Unit — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Tarek Hiwot, M.D.

Conditions Type 2 Diabetes; Type 2 diabetes; insulin resistance