Parkinson's Disease (PD)Phase 1/2STEPNCT07142044
Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
A Phase 1/2 study testing EC5026 oral tablet in people with Parkinson's Disease (PD), run by EicOsis Human Health Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- EC5026 oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Participants must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.
- Participants must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including coagulation panel, blood cell counts, comprehensive metabolic panel analytes, and creatinine clearance (60 cm3/min or greater). Clinical laboratory tests results that are consistent with known, stable comorbidities will be allowed as long as the comorbidities do not represent an exclusion criteria per se.
- 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.
Who cannot join
- 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.
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- 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).
- Participants with clinically significant abnormalities on screening vital signs, laboratory tests, and/or ECG, per investigator's judgement. Participants with poor venous access will also be excluded.
- Participants with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).
- Participants with a history of disorders of the hypothalamic-pituitary-adrenal axis, including adrenal insufficiency and Cushing's, or with a history of disorders of the hypothalamic-pituitary-gonadal axis, including hypogonadism.
- Participants with any of the following blood values at screening:
- Abnormal plasma renin and/or aldosterone value
- Morning cortisol level <5 mcg/dL
- ACTH stimulated cortisol levels <18 mcg/dL at 60 minutes after ACTH injection at screening, or
- Abnormal FSH, LH, testosterone (for males), or estradiol (for females, unless post-menopausal)
- Participants who have used any topical, oral, or intravenous exogenous corticosteroids within 12 weeks and/or intra-articular exogenous corticosteroids within 6 months prior to the start of the trial, or who plan on using them during the study.
- Participants who have used chemotherapy agents, or who have a personal history of cancer or cancer in first degree relatives suggestive of elevated cancer risk, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening.
- Participants who have used (within 14 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are moderate or strong CYP3A4 inducers or inhibitors.
- Participants who have used (within 14 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are moderate or strong CYP3A4 inhibitors (e.g., grapefruit juice).
- Participants with difficulty in swallowing oral medications
- Participants who have used any other investigational drug within 1 month or 5 half-lives, whichever is longer, prior to enrollment.
- Participants with a documented history of difficult lumbar puncture procedures, to the investigator's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis
Sacramento, California, 95817
About this study
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?
Read more
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
Read the detailed 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 bioavailable polyunsaturated fatty acid epoxides, known as epoxy fatty acids (EpFAs). EpFAs are potent, endogenous fatty acids that are highly produced in areas of damaged and inflamed tissue but are rapidly metabolized by sEH in vivo. Therefore, selective inhibition of sEH prolongs and enhances the anti-inflammatory activity of EpFAs. Several studies have identified the sEH enzyme as a potential therapeutic target for modulating neuroinflammatory responses in PD.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- EC5026 oral tablet, Placebo
- Keywords
- EC5026, Parkinson's Disease, Soluble Epoxide Hydrolase, sEH, Soluble Epoxide Hydrolase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC5026 oral tabletDrug
Oral soluble epoxide hydrolase inhibitor
PlaceboDrug
Matching oral placebo
| Study group | Role | What they receive |
|---|---|---|
| EC5026 2 mg daily | Experimental | Once-daily, oral dose of 2 mg of EC5026 for 28 consecutive days Receives: Drug: EC5026 oral tablet |
| EC5026 4 mg daily | Experimental | Once-daily, oral dose of 4 mg of EC5026 for 28 consecutive days Receives: Drug: EC5026 oral tablet |
| Placebo | Placebo comparator | Once-daily, matching placebo for each dose cohort, orally for 28 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EicOsis Human Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- William K Schmidt, PhD, Study director, EicOsis Human Health Inc.Lin Zhang, MD, PhD, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142044
- Sponsor's protocol ID
- EC5026-1-05
- Acronym
- STEP
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
- ClinicalTrials.gov ID
- NCT07142044
- Acronym / sponsor ID
- STEP / EC5026-1-05
- Conditions
- Parkinson's Disease (PD)
- Keywords
- EC5026, Parkinson's Disease, Soluble Epoxide Hydrolase, sEH, Soluble Epoxide Hydrolase inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- EicOsis Human Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis, Michael J. Fox Foundation for Parkinson's Research
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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 bioavailable polyunsaturated fatty acid epoxides, known as epoxy fatty acids (EpFAs). EpFAs are potent, endogenous fatty acids that are highly produced in areas of damaged and inflamed tissue but are rapidly metabolized by sEH in vivo. Therefore, selective inhibition of sEH prolongs and enhances the anti-inflammatory activity of EpFAs. Several studies have identified the sEH enzyme as a potential therapeutic target for modulating neuroinflammatory responses in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EC5026 2 mg daily | Experimental | Drug: EC5026 oral tabletOnce-daily, oral dose of 2 mg of EC5026 for 28 consecutive days |
| EC5026 4 mg daily | Experimental | Drug: EC5026 oral tabletOnce-daily, oral dose of 4 mg of EC5026 for 28 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboOnce-daily, matching placebo for each dose cohort, orally for 28 consecutive days. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC5026 oral tabletOral soluble epoxide hydrolase inhibitor | Drug | EC5026 2 mg daily, EC5026 4 mg daily |
| PlaceboMatching oral placebo | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]
Time frame: 56 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William K Schmidt, PhD study director
EicOsis Human Health Inc.
Lin Zhang, MD, PhD principal investigator
UC Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EC5026 oral tablet in people with Parkinson's Disease (PD), run by EicOsis Human Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William K Schmidt, PhD (650-438-3018, wkschmidt@eicosis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability] (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.