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A Study to Assess Safety, Tolerability and Exposure of 4ET1103 in Healthy Human Volunteers

NCT07586514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this study

Summary

This study will dose healthy human volunteers with either active drug (4ET1103) or placebo. Each study subject will receive a single dose of either active drug or placebo, and will then be monitored for safety, tolerability and exposure of active drug.

Conditions

  • Neuropathic Pain

Interventions

DRUG

Treatment for neuropathic pain

MNK inhibitor for treatment of neuropathic pain

DRUG

placebo

placebo for MNK inhibitor

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • 4E Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kristie Miller, MD · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2025-08-18
Completion
2025-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT07586514 on ClinicalTrials.gov