NCT06089837

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Oral EC5026 in Healthy Subjects

A Phase 1b Multiple Ascending Dose (MAD) Study of EC5026 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: EicOsis Human Health Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Two Phase 1a studies - a Phase 1a single ascending dose (SAD) study and a Phase 1a fed-fasted study - have been conducted, evaluating the safety, tolerability, PK, and food effects of single oral doses of EC5026 ranging 0.5 to 24 mg. The present study will evaluate the safety, tolerability, and PK of 2 sequential ascending dose regimens of EC5026, administered once daily for 7 consecutive days, in healthy volunteers.

Detailed description

This is double-blind, randomized, placebo-controlled Phase 1b multiple ascending dose (MAD) study to investigate the safety, tolerability, and pharmacokinetics (PK) of 2 sequential dose regimens of oral EC5026 in healthy male and female subjects. EC5026 is an inhibitor of the soluble Epoxide Hydrolase (sEH) enzyme developed as a first-in-class analgesic for the treatment of pain. sEH is an enzyme that is downstream in the cytochrome P450 (CYP) pathway of the arachidonic acid (AA) cascade. The sEH enzyme is responsible of metabolizing a class of epoxy-fatty acids known as epoxyeicosatrienoic acids (EETs), which are potent, naturally occurring analgesics. EETs are produced at high concentrations in areas of tissue damage and inflammation, but are rapidly metabolized by the sEH enzyme into inactive compounds. Effective inhibition of sEH activity prolongs the ability of EETs to exert their analgesic activity. This Phase 1b MAD study will be enrolling 16 healthy male and female subjects 18 years and older. EC5026 and placebo will be administered orally in tablets. Study drug (active or placebo) will be administered as a single oral dose daily, for 7 consecutive days. Subjects assigned to the active drug will receive a single loading dose on Day 1 and a single maintenance dose on Days 2-7. The dose regimens to be assessed in this Phase 1b trial correspond to the following loading dose and maintenance dose pairs: 4 mg/2 mg (Cohort 1, total cumulative 7-day oral dose of 16 mg), and 8 mg/4 mg (Cohort 2, total cumulative 7-day oral dose of 32 mg).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	EC5026 oral tablet	2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days. Oral doses of EC5026 tested in each cohort: 4 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 (Cohort 1) 8 mg loading dose on Day 1 / 4 mg Maintenance dose on Days 2-7 (Cohort 2)
DRUG	Placebo oral tablet	2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days. Subject assigned to the Placebo Arm will receive 7 days of matching placebo oral tablets in each Cohort.

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-03-13
• Completion: 2024-05-12
• First posted: 2023-10-18
• Last updated: 2025-01-08

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study