CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
EC5026 oral capsule +1 moredrug
Likely dose
EC5026 oral capsule 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04228302
NCT04228302Phase 1Completed
CompareCT.gov

A Single-Center, Double-Blind, Placebo-Controlled, Phase 1A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of Oral EC5026 in Healthy Male and Female Subjects

EicOsis Human Health Inc.·interventional·Posted Jan 14, 2020·Updated Jul 1, 2021

In Brief

A Phase 1 clinical trial evaluating EC5026 oral capsule and Placebo oral capsule for Healthy Adults. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is a first-in-human study with EC5026, a new drug candidate intended to treat neuropathic pain. The purpose of the study is to provide initial safety, tolerability, and pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adults
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 14, 2020
Enrollment StartDec 9, 2019
Primary CompletionJul 7, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.5 years ago

Interventions

EC5026 oral capsuledrug

5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort). Oral doses of EC5026 tested in each cohort: 0.5 mg (Cohort 1), 2 mg (Cohort 2), 8 mg (Cohort 3), 16 mg (Cohort 4), and 24 mg (Cohort 5). A blinded sentinel group of 2 subjects (1 active and 1 placebo) will be dosed at least 2 days before the remaining 6 subjects (5 active and 1 placebo) will receive blinded doses of active study drug or placebo.

Placebo oral capsuleother

5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort)