Clinical Trial

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

Study acronym: STEP
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-19; most recent amendment 2026-07-09.
Trial Details
NCT Number NCT07142044
Lead Sponsor EicOsis Human Health Inc.
Collaborators: University of California, Davis, Michael J. Fox Foundation for Parkinson's Research
Conditions Parkinson's Disease (PD)
Enrollment 18 participants
Start Date 2025-11-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-10