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

NCT07142044 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-09-05

No results posted yet for this study

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

Conditions

  • Parkinson's Disease (PD)

Interventions

DRUG

EC5026 oral tablet

Oral soluble epoxide hydrolase inhibitor

DRUG

Placebo

Matching oral placebo

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • EicOsis Human Health Inc.

    lead INDUSTRY

Principal Investigators

  • William K Schmidt, PhD · EicOsis Human Health Inc.

  • Lin Zhang, MD, PhD · UC Davis Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07142044 on ClinicalTrials.gov