At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Once-daily Dosing of IMM-124E (Travelan®) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC)
In Brief
A Phase 2 clinical trial evaluating Travelan and Placebo for Diarrhea and 2 related conditions. Completed, enrolled 63 participants across 1 site.
Signals
Detailed Summary
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.
Study Details
Timeline
Arms & Interventions
IMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally once daily for 7 days.
ProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. The same dosing schedule of 1200mg will be taken orally once-daily for 7 days.
Interventions
Travelan tablets (1200mg) administered orally once daily for 7 days
Placebo (1200mg) tablets administered orally once daily for 7 days