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

NCT04236778 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VE303-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Safety of VE303 measured by incidence adverse events (AEs)

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

  12 months post-dose

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

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

  12 months post-dose

Secondary Outcomes (3)

• Evaluate the colonization of the intestinal microbiota with VE303 component bacteria

  12 months post-dose

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

  12 months post-dose

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

  12 months post-dose

Study Arms (10)

Cohort 1

EXPERIMENTAL

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

Drug: VE303; Drug: Oral Vancomycin

Cohort 2

EXPERIMENTAL

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

Drug: VE303; Drug: Oral Vancomycin

Cohort 3

EXPERIMENTAL

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

Drug: VE303; Drug: Oral Vancomycin

Cohort 4

EXPERIMENTAL

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

Drug: VE303; Drug: Oral Vancomycin

Cohort 5

EXPERIMENTAL

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

Drug: VE303; Drug: Oral Vancomycin

Cohort 6

EXPERIMENTAL

Cohort 6 received 21 days of 10 doses daily of VE303

Drug: 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

Drug: VE303; Drug: Oral Vancomycin

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

Drug: VE303; Drug: Oral Vancomycin

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

Drug: VE303; Drug: Oral Vancomycin

Vancomycin only

PLACEBO COMPARATOR

This cohort only received oral vancomycin.

Drug: Oral Vancomycin

Interventions

VE303 DRUG

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

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Oral Vancomycin DRUG

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

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 7; Cohort 8; Cohort 9; Vancomycin only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vedanta Biosciences, Inc.: lead

Study Sites (1)

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This Phase 1a/1b, first-in-human, open-label, single-center, dose-escalation study will evaluate the safety and microbiota changes induced by ingestion of VE303 following administration of oral vancomycin and VE303 administered without vancomycin pre-treatment in healthy adult subjects. Approximately 48 subjects are anticipated for enrollment, unless intermediate cohorts are required, in which case, up to an additional 18 subjects (for a total of approximately 66 subjects) may be enrolled.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 22, 2020
• Study Start: November 28, 2017
• Primary Completion: March 11, 2019
• Study Completion: March 11, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)