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Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, In Healthy and VRE-Colonized Subjects

NCT05715619 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-14

No results posted yet for this study

Summary

The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of VRELysin in healthy and VRE-colonized adults.

Conditions

  • Vancomycin-Resistant Enterococcal Colonization

Interventions

BIOLOGICAL

VRELysin™

A cocktail of lytic Enterococcus-specific bacteriophages orally administered with sodium bicarbonate solution

OTHER

Placebo

Placebo orally administered with sodium bicarbonate solution

Sponsors & Collaborators

  • Intralytix, Inc.

    lead INDUSTRY

Principal Investigators

  • Minh-Hong Nguyen, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05715619 on ClinicalTrials.gov