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Completed

NCT Number: NCT04236778

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VE303

Drug

The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.

Oral Vancomycin

Drug

Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.

Primary outcomes

  1. Safety of VE303 measured by incidence adverse events (AEs)

    Time frame: 12 months post-dose

    Measured in terms of incidence of AEs according to CTCAE V4.0

  2. Tolerability of VE303 using modified PROMIS questionnaire (v1.0)

    Time frame: 12 months post-dose

    Characterized the highest well tolerated dose regimen of VE303 using modified PROMIS questionnaire (v1.0)

Secondary outcomes

  1. Evaluate the colonization of the intestinal microbiota with VE303 component bacteria

    Time frame: 12 months post-dose

    Measurement of VE303 strain colonization in stool samples was performed using a metagenomic sequencing-based bioinformatic approach. A strain-specific marker panel was employed to characterize the relative abundance of VE303 strains in the intestinal microbiota.

  2. Evaluate the changes in the intestinal microbiota due to VE303 dosing.

    Time frame: 12 months post-dose

    Measurement of intestinal microbiota due to VE303 dosing was performed using metagenomic sequencing- and metabolomic analysis-based approaches. Thus, focusing on taxonomic and functional changes occurring in the gut.

  3. Evaluate the metabolomic changes in stool due to VE303 dosing.

    Time frame: 12 months post-dose

    Quantified changes in pool of metabolite levels (bile acids and short-chain fatty acids) from stool samples

Sponsors and collaborators

Lead sponsor

Vedanta Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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