Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
EicOsis Human Health Inc.
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
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 bioavailabl…
Eligibility
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult males and females, 50 to 80 years of age (inclusive) at the time of Screening. 2. Able to understand the consent form, and to provide voluntary written informed consent. 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study. 4. Confirmed diagnosis of idiopathic Parkinson's Disease according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria. 5. Off state Hoehn \& Yahr below Stage 3 at the time of Screening. 6. Participants must be on stable doses of L-dopa w…
Interventions
- DrugEC5026 oral tablet
Oral soluble epoxide hydrolase inhibitor
- DrugPlacebo
Matching oral placebo
Location
- University of California DavisSacramento, California