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Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model

NCT05933525 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-22

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled study to investigate if Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.

Conditions

  • Diarrhea
  • Travelers Diarrhea
  • Infectious Diarrhea

Interventions

BIOLOGICAL

Travelan

6 Travelan tablets (1200mg) administered orally for 7 days

OTHER

Placebo

6 tablets of placebo (1200mg) administered orally for 7 days

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Naval Medical Research Center

    collaborator FED

  • Immuron Ltd.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MB,ChB,FACP · Pharmaron Clinical Pharmacology Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2024-07-01
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05933525 on ClinicalTrials.gov