Actively Recruiting
Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
Led by EicOsis Human Health Inc. · Updated on 2025-09-05
18
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
E
EicOsis Human Health Inc.
Lead Sponsor
U
University of California, Davis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, how the body processes, and the target engagement of the oral drug candidate EC5026 in adults with Parkinson's Disease. This Phase 1b study also explores whether EC5026 may improve Parkinson's symptoms. The drug EC5026 works by inhibiting an enzyme involved in inflammation, which might affect pathways related to the disease. The study compares EC5026 to a placebo to answer key questions about safety, drug levels in blood and spinal fluid, and effects on biological targets. Participants will receive either 2 mg or 4 mg of EC5026 or a matching placebo once daily for 28 consecutive days. The study is randomized and double-blind, meaning neither participants nor researchers know who receives which treatment. The trial includes two ascending dose regimens and a placebo group. This design helps evaluate safety and effects at different dosage levels over the 28-day treatment period. During the study, participants will attend frequent clinic visits for checkups, blood and spinal fluid tests, and questionnaires. Researchers will monitor adverse events and serious adverse events for 56 days. They will also measure drug levels in the body and biological markers related to Parkinson's Disease. Participants must be able to complete all study procedures and assessments, contributing to a total involvement duration that includes treatment and follow-up periods.
CONDITIONS
Brief Title
Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and expected to remain stable.
- Participants must be in overall stable condition based on medical history, physical exam, lab tests, and ECG.
- Participants must have normal or not clinically significant lab test results, including coagulation panel, blood counts, metabolic panel, and creatinine clearance (60 cm3/min or greater).
- Participants must have a negative urinary drug screen and alcohol breath test.
- Abstention from other investigative or non-approved drugs during the trial.
- Male participants not surgically sterile and their female partners must agree to use contraception during and 2 months after the study.
- Male participants must not donate sperm during the study and for 12 months after last dose.
- Female participants must be non-pregnant, non-lactating, postmenopausal for at least 1 year or surgically sterile, or use two forms of effective contraception from 28 days before enrollment until 2 months after last dose.
- Participants must be able to speak, read, and understand English to complete assessments.
You will not qualify if you...
- Atypical parkinsonian syndrome or secondary parkinsonism.
- Family history of early onset PD (under 50 years) or known genetic cause of PD.
- Other significant neurologic diseases that could affect study assessments.
- Unstable Parkinson's treatment regimen or likely to require changes in L-dopa therapy.
- Presence of PD psychosis, dementia, or psychiatric conditions affecting consent or compliance.
- Severe dyskinesia interfering with assessments.
- History of neurosurgery for PD or tremor.
- Significant medical, surgical, or lab abnormalities judged by the Investigator.
- Clinically unstable or significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious diseases.
- Significant abnormalities on vital signs, labs, or ECG; poor venous access.
- Family history of significant cardiac disease.
- Disorders of hypothalamic-pituitary-adrenal or gonadal axes.
- Abnormal blood values related to renin, aldosterone, cortisol, FSH, LH, testosterone, or estradiol.
- Recent use of corticosteroids or plan to use during study.
- Recent chemotherapy or cancer history within 5 years except fully excised nonmetastatic skin cancer.
- Use or planned use of drugs or supplements that affect CYP3A4 within 14 days of randomization.
- Difficulty swallowing oral medications.
- Use of investigational drugs within 1 month or 5 half-lives prior to enrollment.
- History of difficult lumbar puncture procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive once-daily oral doses of EC5026 or matching placebo for 28 consecutive days to evaluate safety, tolerability, and exploratory efficacy.
Daily dosing with multiple visits during treatment
Duration - 28 days
Participants are monitored for safety and adverse events after completing the treatment period.
Approximately weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
W
William K Schmidt, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here