Trial | NCT04236778  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    39
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.
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.
Study Started
Nov 28
2017
Primary Completion
Mar 11
2019
Study Completion
Mar 11
2019
Last Update
Jan 27
2020

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.

Cohort 1 Experimental

Cohort 1 received oral vancomycin followed by a single dose of VE303.

Cohort 2 Experimental

Cohort 2 received oral vancomycin followed by a single day of 5 doses of VE303.

Cohort 3 Experimental

Cohort 3 received oral vancomycin followed by a single day of 10 doses of VE303.

Cohort 4 Experimental

Cohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303.

Cohort 5 Experimental

Cohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303

Cohort 6 Experimental

Cohort 6 received 21 days of 10 doses daily of VE303

Cohort 7 Experimental

Cohort 7 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days

Cohort 8 Experimental

Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days

Cohort 9 Experimental

Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days

Vancomycin only Placebo Comparator

This cohort only received oral vancomycin.

Criteria 

Key Inclusion Criteria:

Subjects who are judged to be in general good health
Body mass index between 18.5 and 30 kg/m2
Women either of non-child bearing potential or using a highly effective form of contraception
Men using a highly effective method of contraception

Key Exclusion Criteria:

Past or present clinically significant diseases that may affect the outcome of the study
Taking any medications, herbal preparations, or natural substances, live bacteria products, or food that impacts or alter GI flora
Use of proton pump inhibitors or other short or long acting antacid medications
Taking or has received an investigation drug or treatment within 60 days of inpatient admission
Known allergies to involved study drugs
Chronic constipation or diarrhea
History of or active IBD
No Results Posted