NCT07142044

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: EicOsis Human Health Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a double-blind, randomized, placebo-controlled Phase 1b multiple ascending dose (MAD) study to be conducted in adult male and female participants with Parkinson's Disease. The aim is to evaluate the safety, pharmacokinetics (PK), target engagement, and exploratory efficacy, of 2 ascending dose regimens of oral EC5026 in participants with Parkinson's Disease. The study drug, EC5026, is an orally bioavailable inhibitor of an enzyme, soluble epoxide hydrolase (sEH), that is being developed as a first-in-class anti-inflammatory agent. Inhibiting sEH maintains concentrations of bioavailable polyunsaturated fatty acid epoxides, known as epoxy fatty acids (EpFAs). EpFAs are potent, endogenous fatty acids that are highly produced in areas of damaged and inflamed tissue but are rapidly metabolized by sEH in vivo. Therefore, selective inhibition of sEH prolongs and enhances the anti-inflammatory activity of EpFAs. Several studies have identified the sEH enzyme as a potential therapeutic target for modulating neuroinflammatory responses in PD.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	EC5026 oral tablet	Oral soluble epoxide hydrolase inhibitor
DRUG	Placebo	Matching oral placebo

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-08-26
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study