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
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.
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.
Parallel
EC5026 oral tablet
DrugOral soluble epoxide hydrolase inhibitor
Placebo
DrugMatching oral placebo
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.
Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma and cerebrospinal fluid levels of EC5026
Standard validated EC5026 measurement platform will be used
Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma and cerebrospinal fluid target engagement biomarkers.
Target engagement biomarkers will include changes from baseline of a validated analytical platform of inflammatory cytokines, neurological markers including target inflammatory genes tied to the mechanism of action, ER-stress response genes, and Parkinson's Disease specific biomarkers (including alpha-synuclein, Abeta42, pTau-181, GFAP, and Neurofilament Light).
Change from Baseline in Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Score (Day 14)
Change from Baseline in Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Score on Day 14. The Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) is a comprehensive tool used to assess Parkinson's Disease (PD) symptoms and severity through a series of questions rated by clinicians, patients, and caregivers. Scores are on a 0-4 scale, with higher scores indicating a greater impact of PD symptoms. The scale is divided into four parts, covering non-motor and motor experiences of daily living, motor examination, and motor complications.
Change from Baseline in Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Score (Day 28)
Change from Baseline in Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Score on Day 28. The Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) is a comprehensive tool used to assess Parkinson's Disease (PD) symptoms and severity through a series of questions rated by clinicians, patients, and caregivers. Scores are on a 0-4 scale, with higher scores indicating a greater impact of PD symptoms. The scale is divided into four parts, covering non-motor and motor experiences of daily living, motor examination, and motor complications.
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EicOsis Human Health Inc.
Lead sponsor
University of California, Davis
Collaborator
Michael J. Fox Foundation for Parkinson's Research
Collaborator
