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

Part of paid clinical trials in Sacramento, California.

Sponsor
EicOsis Human Health Inc.
Study ID
NCT07142044
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • EC5026 oral tablet — DRUG
    Oral soluble epoxide hydrolase inhibitor
  • Placebo — DRUG
    Matching oral placebo

Study Details

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

Key Dates

Start date
Oct 31, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EC5026 2 mg daily
    Once-daily, oral dose of 2 mg of EC5026 for 28 consecutive days
  • Experimental: EC5026 4 mg daily
    Once-daily, oral dose of 4 mg of EC5026 for 28 consecutive days
  • Placebo Comparator: Placebo
    Once-daily, matching placebo for each dose cohort, orally for 28 consecutive days.

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability] [ Time Frame: 56 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817-

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By research site
University of California Davis· Sacramento, CA

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