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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236778
• Other study ID #: VE303-01
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2017
• Est. completion date: March 11, 2019

Study information

• Verified date: January 2020
• Source: Vedanta Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Vedanta Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Evaluate the colonization of the intestinal microbiota with VE303 component bacteria	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.	12 months post-dose
Secondary	Evaluate the changes in the intestinal microbiota due to VE303 dosing.	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.	12 months post-dose
Secondary	Evaluate the metabolomic changes in stool due to VE303 dosing.	Quantified changes in pool of metabolite levels (bile acids and short-chain fatty acids) from stool samples	12 months post-dose