drugset / Trial / NCT04236778

First-in-human Study of VE303 in Healthy Adult Volunteers

NCT04236778

Phase 1 Completed 39 enrolled Vedanta Biosciences, Inc.
Non-randomizedSequentialOpen-labelOther

Summary

This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.

Timeline

Start
2017-11-28
Primary completion
2019-03-11
Completion
2019-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject VE303 Other / unclassified
Background Vancomycin Other / unclassified Oral

Indications

No indication recorded.