A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers

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

The primary objective of this study 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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: PATAS Trifluoroacetate

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tarek Hiwot, M.D.; Phone Number: 44 7391 537 158; Email: tarek.hiwot@adipopharma.us
• Study Contact Backup: Name: Michael J Fare; Phone Number: 203-671-4351; Email: michael.fare@adipopharma.us

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Recruiting
      • Medpace Clinical Pharmacology Unit
      • Contact: Medical Director
    • Cincinnati, Ohio, United States, 45227
      • Recruiting
      • Medpace Clinical Pharmaology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Healthy subjects, Placebo	Drug: Placebo; Excipient only formulation, without active compound
Experimental: Healthy Subjects, Active	Drug: PATAS Trifluoroacetate; A drug targeting the interaction between the ALMS1 protein and alpha-PKC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety -- 1A	Incidence and severity (using CTCAE version 5.0.) of treatment-emergent AEs and SAEs and evaluation of pharmacokinetic data	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - 1B	Efficacy of treatment measured by CGM and results of OGTT	29 Days

Collaborators and Investigators

• Sponsor: AdipoPharma LLC
• Investigators: Study Chair: Vincent Marion, Ph.D., AdipoPharma LLC

Study record dates

Study Major Dates

• Study Start (Estimated): January 27, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 diabetes; insulin resistance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: PATAS-CL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data is confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No