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

NCT06089837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-01-08

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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.

Sponsors & Collaborators

  • EicOsis Human Health Inc.

    lead INDUSTRY

Principal Investigators

  • Cory D Sellwood, MBChB · New Zealand Clinical Research

  • William K Schmidt, PhD · EicOsis Human Health Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2024-03-13
Completion
2024-05-12
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089837 on ClinicalTrials.gov