Actively Recruiting
A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers
Led by AdipoPharma LLC · Updated on 2026-02-23
56
Participants Needed
2
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 to 55 years at consent
- Able and willing to provide written informed consent before study procedures
- Body mass index (BMI) between 20.0 and 35.0 kg/m2 at screening
- Generally in good health based on medical history, physical exam, vital signs, lab tests, and ECG
- Female participants must have negative pregnancy tests at screening and before dosing, not be pregnant or lactating, and avoid pregnancy until 90 days after last dose
- Negative test for severe acute respiratory syndrome coronavirus 2 at check-in
- Willing to comply with all study procedures throughout the study duration
You will not qualify if you...
- History of asthma, eczema, or other allergic conditions or severe hypersensitivity (non-active hay fever allowed)
- Liver function tests above normal limits at screening or check-in
- Estimated glomerular filtration rate ≤ 90 mL/min/1.73 m2 at screening or check-in
- Thyroid-stimulating hormone outside normal range at screening
- History of unexplained syncope, cardiac arrest, arrhythmias, torsades de pointes, or structural heart disease
- Personal or family history of long QT syndrome
- Any clinically significant disease or disorder judged exclusionary by investigator
- Abnormal pulse rate (<40 or >100 bpm) or blood pressure (systolic <90 or >140 mmHg, diastolic <50 or >90 mmHg) at screening
- Clinically significant ECG abnormalities including prolonged QTcF interval (>450 ms males, >470 ms females)
- Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at screening
- Use of investigational products within 30 days prior to dosing or participation in more than 3 clinical studies within 12 months
- Known or suspected hypersensitivity to PATAS or formulation components (sodium hydroxide, mannitol)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Actively Recruiting
2
Medpace Clinical Pharmaology Unit
Cincinnati, Ohio, United States, 45227
Actively Recruiting
Research Team
T
Tarek Hiwot, M.D.
CONTACT
M
Michael J Fare
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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