RecruitingPhase 1Phase 2NCT07142044

Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)


Sponsor

EicOsis Human Health Inc.

Enrollment

18 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the oral drug candidate EC5026 is safe and targets the correct pathways to treat Parkinson's Disease in adults. It will also learn about the levels of drug that are achieved in blood and in the fluid surrounding the brain (spinal fluid). The main questions it aims to answer are: * Is EC5026 safe in adults with Parkinson's Disease? * What are the levels of EC5026 achieved after oral administration for 28 days? * What molecules or pathways does EC5026 target, and to what extent? In addition, although it is not one of the primary aims of the study, this clinical trial will also explore if oral administration of EC5026 improves the symptoms of Parkinson's Disease. Researchers will compare EC5026 to a placebo (a look-alike substance that contains no drug). Participants will: * Take EC5026 or a placebo every day for 28 consecutive days * Visit the clinic for frequent checkups, blood tests, spinal fluid tests, and questionnaires


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called EC5026 to see if it is safe, well tolerated, and potentially helpful for people with Parkinson's disease. It is an early-phase study focused on safety and initial signs of effectiveness. **You may be eligible if...** - You are between 50 and 80 years old - You have been diagnosed with Parkinson's disease (not caused by medications or other conditions) - Your Parkinson's is at or below stage 3 (mild to moderate) - You have been on a stable Parkinson's medication regimen for at least 30 days - You are not pregnant, breastfeeding, or planning to become pregnant during the study **You may NOT be eligible if...** - You have atypical Parkinson's or Parkinson's caused by medications, toxins, or other neurological conditions - You have significant dementia, psychosis, or severe mood disorders - You have recently had a heart attack, unstable heart condition, or serious kidney/liver/lung disease - You have used corticosteroids, cancer medications, or strong CYP3A4 interacting drugs recently - You have a history of hormone gland disorders (adrenal, pituitary, gonadal) - You have difficulty swallowing pills 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

DRUGEC5026 oral tablet

Oral soluble epoxide hydrolase inhibitor

DRUGPlacebo

Matching oral placebo


Locations(1)

University of California Davis

Sacramento, California, United States

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NCT07142044


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