A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers (NCT07223333) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers
United States56 participantsStarted 2026-01-27
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF);
. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
. Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening;
. 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);
. 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;
. Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and
. Willing to comply with all study procedures and requirements throughout the duration of the study.
Exclusion criteria
. Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial testing PATAS Trifluoroacetate for the first time in humans at single ascending doses, what does that mean for how much is actually known about its safety and effectiveness for managing my Type 2 Diabetes right now?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new participants — does that change whether this drug could ever be an option for me, and are there related studies I should be watching for?
3Since the primary goal of this study is safety monitoring rather than measuring blood sugar control or diabetes outcomes, would it make more sense for me to focus on established Type 2 Diabetes treatments first while this research is still in very early stages?
4Given that this trial involves healthy volunteers receiving single doses, how does that study design affect what doctors will actually learn about how PATAS Trifluoroacetate might work for someone who already has Type 2 Diabetes?
5Are there any other Phase 1 or Phase 2 trials for newer diabetes medications that might be a better fit for my situation, given that this particular study isn't currently accepting new participants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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);
. 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.
. History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease;
. Personal or family history of long QT syndrome;
. 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;
. 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.