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

NCT07142044 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: EC5026-1-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

EC5026; Parkinson's Disease; Soluble Epoxide Hydrolase; sEH; Soluble Epoxide Hydrolase inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]

  All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities will be used to code all AEs.

  56 days

Other Outcomes (17)

• Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma and cerebrospinal fluid levels of EC5026

  56 days

• Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma and cerebrospinal fluid target engagement biomarkers.

  56 days.

• Change from Baseline in Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Score (Day 14)

  Day 14

Study Arms (3)

EC5026 2 mg daily

EXPERIMENTAL

Once-daily, oral dose of 2 mg of EC5026 for 28 consecutive days

Drug: EC5026 oral tablet

EC5026 4 mg daily

EXPERIMENTAL

Once-daily, oral dose of 4 mg of EC5026 for 28 consecutive days

Drug: EC5026 oral tablet

Placebo

PLACEBO COMPARATOR

Once-daily, matching placebo for each dose cohort, orally for 28 consecutive days.

Drug: Placebo

Interventions

EC5026 oral tablet DRUG

Oral soluble epoxide hydrolase inhibitor

EC5026 2 mg daily; EC5026 4 mg daily

Placebo DRUG

Matching oral placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females, 50 to 80 years of age (inclusive) at the time of Screening.
• Able to understand the consent form, and to provide voluntary written informed consent.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
• Confirmed diagnosis of idiopathic Parkinson's Disease according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria.
• Off state Hoehn \& Yahr below Stage 3 at the time of Screening.
• Participants must be on stable doses of L-dopa with or without other adjunctive PD therapy for at least 30 days prior to enrollment. Doses should be expected to remain stable for the duration of the study.
• Participants must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.

You may not qualify if:

• Participants must have a negative urinary drug screen (UDS) for illicit drugs and a negative alcohol breath test.
• Abstention from use of other investigative or non-approved drugs for the duration of the trial
• Male participants who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months after receiving the last dose of study drug.
• Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
• Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, 'clipping or tying tubes,' or hysterectomy) for at least 3 months, or they must agree to use two forms of highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year) from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after receiving the last dose of study drug. Postmenopausal status will be defined as follows: minimum 1 year; amenorrhea duration of 12 consecutive months and a serum FSH value \>40 IU/L; postmenopausal status must be confirmed by an FSH test at Screening). Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and/or barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants/Participant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).
• Participants must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments.
• Atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs or toxins, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or non-PD degenerative disease).
• Family history of early onset PD (age \<50 years) or known personal genetically causal etiology of PD.
• Diagnosis of any other clinically significant neurologic disease that may confound the assessment of the study drug on PD symptoms
• Not stabilized with current therapeutic regimen for PD or likely to require changes in L-dopa therapy over the duration of the trial.
• Presence of PD psychosis or dementia, or other neuropsychiatric or psychiatric conditions impeding informed consent or compliance with study interventions.
• Severe dyskinesia (defined as per MDS-UPDRS) during a "normal day" that would significantly interfere with the participant's ability to perform study assessments.
• History of neurosurgery for PD or tremor.
• Clinically significant medical, surgical, or laboratory abnormalities in the judgement of the Investigator.
• Participants with any clinically unstable or significant cardiovascular (including acute coronary syndrome within the prior year to Screening), renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious disease (including HIV infection).

Sponsors & Collaborators

• EicOsis Human Health Inc.: lead
• University of California, Davis: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Interventions

EC5026

Study Officials

• William K Schmidt, PhD

  EicOsis Human Health Inc.

  STUDY DIRECTOR

• Lin Zhang, MD, PhD

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William K Schmidt, PhD

CONTACT

650-438-3018; wkschmidt@eicosis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will consist of two independent dose cohorts, Cohort 1 and Cohort 2. Each cohort will enroll eighteen (9) unique participants. In each cohort, 9 adults with Parkinson's Disease will be randomized to receive EC5026 or a matching placebo (2:1 randomization ratio). EC5026 and placebo will be administered orally in tablets, once daily, for 28 consecutive days. In Cohort 1, study participants will receive a daily dose of 2 mg of EC5026 or matching placebo; in Cohort 2, study participants will receive a daily dose of 4 mg of EC5026 or matching placebo. Dosing will be inpatient for the first 4 doses (facility discharge on Day 4 of the study period) and outpatient thereafter. There will be a 28 day follow up period after receiving the last dose of EC5026 or placebo.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)