This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Healthy Volunteers

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

Sponsored by Vedanta Biosciences, Inc.

About this trial

Last updated 5 years ago

Study ID

VE303-01

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 60 Years
All
All

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the Participation Requirements?

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

Locations

Location

Status