NCT04236778

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

A Phase 1a/1b, First-in-human, Open-label Study of Escalating Doses of VE303 in Healthy Adult Volunteers With or Without Vancomycin Pre-treatment to Evaluate Safety, Dosing, and Pharmacodynamics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Vedanta Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

VE303 is a rationally-defined bacterial consortium candidate being developed for the prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under GMP conditions.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VE303	The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
DRUG	Oral Vancomycin	Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-03-11
• Completion: 2019-03-11
• First posted: 2020-01-22
• Last updated: 2020-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study