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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
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• 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.

• 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.

Locations
United States
California
University of California Davis
RECRUITING
Sacramento
Contact Information
Primary
William K Schmidt, PhD
wkschmidt@eicosis.com
650-438-3018
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2027-06
Participants
Target number of participants: 18
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Michael J. Fox Foundation for Parkinson's Research, University of California, Davis
Leads: EicOsis Human Health Inc.

This content was sourced from clinicaltrials.gov