Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA

Phase 1 Completed 36 enrolled Mark Klempner Bill and Melinda Gates Foundation · collab Pharmaron CPC, Inc. · collab University of Maryland · collab

RandomizedSequentialQuadruple-blindPrevention

Summary

This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of VENBETA6890, an orally administered, human monoclonal IgA.

Timeline

Start: 2025-02-11
Primary completion: 2025-05-22
Completion: 2025-05-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VENBETA6890	Monoclonal antibody	15 mg/kg	Oral

Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA

Summary

Timeline

Drugs

Indications