NCT05715619

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

A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, In Healthy And VRE-Colonized Subjects

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Intralytix, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to determine if VRELysin is safe and effective in adults in a continuous Phase 1/2a trial. Phase 1 will asses the safety of VRELysin in healthy adults, while Phase 2a will evaluate the safety and efficacy of VRELysin in adults colonized with VRE in the gastrointestinal tract. VRELysin is a collection of bacteriophages. Bacteriophages (or phages) are viruses that infect only bacteria. The phages in VRELysin infect a specific type of bacteria called Enterococcus, which can cause gastrointestinal infections. VRELysin is intended to significantly reduce or eliminate vancomycin-resistant Enterococcus (VRE) levels in the human gastrointestinal tract, which in turn, may prevent subsequent infection as well as nosocomial spread.

Conditions

• Vancomycin-Resistant Enterococcal Colonization

Interventions

Type	Name	Description
BIOLOGICAL	VRELysin™	A cocktail of lytic Enterococcus-specific bacteriophages orally administered with sodium bicarbonate solution
OTHER	Placebo	Placebo orally administered with sodium bicarbonate solution

Timeline

• Start date: 2023-10-25
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-02-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study