RecruitingPhase 1NCT07223333

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


Sponsor

AdipoPharma LLC

Enrollment

56 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called PATAS Trifluoroacetate for the first time in humans. It is designed to find out whether the drug is safe and how the body processes it. Only healthy volunteers are being recruited — no particular disease is being treated. **You may be eligible if...** - You are a healthy adult between 18 and 55 years old - Your BMI is between 20 and 35 - You are in generally good health, with no significant ongoing medical conditions - Women must not be pregnant, breastfeeding, or planning to become pregnant, and must have a negative pregnancy test - You are willing to follow all study procedures and stay at the clinical research center as required **You may NOT be eligible if...** - You have a significant history of asthma, eczema, or serious allergic reactions - You have abnormal liver function test results - You have any active or significant chronic medical condition (heart, lung, kidney, liver, brain, or psychiatric) - You have had cancer in the past 5 years (other than minor skin cancer) - You have donated more than 500 mL of blood in the past 56 days - You have used recreational drugs or have a history of substance abuse - You have participated in another clinical drug trial within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPATAS Trifluoroacetate

A drug targeting the interaction between the ALMS1 protein and alpha-PKC

DRUGPlacebo

Excipient only formulation, without active compound


Locations(2)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

Medpace Clinical Pharmaology Unit

Cincinnati, Ohio, United States

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NCT07223333


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