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

Phase 1

Recruiting

• Conditions: Vancomycin-Resistant Enterococcal Colonization
• Interventions: Other: Placebo; Biological: VRELysin™

• Registration Number: NCT05715619
• Lead Sponsor: Intralytix, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Status Verified: 2023-10
• Study Start: 2023-10-25
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)
VRELysin™	VRELysin™	Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)

Primary Outcome Measures

Name	Time	Method
Phase 2a: Number and Severity of Solicited and Unsolicited Adverse Reactions	Up to 180 days	Number of subjects reporting solicited and unsolicited AEs, laboratory measures of safety and AEs (up to Day 29) and SAEs (up to Day 180) following treatment with VRELysin or placebo
Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions	Up to 36 days	Number of subjects reporting solicited and unsolicited AEs, laboratory measures of safety, and AEs (up to Day 22) and serious adverse events (SAEs) (up to day 36) following treatment with VRELysin or placebo

Secondary Outcome Measures

Name	Time	Method
Phase 2a: Decolonization of VRE in Stool at Day 15	Day 15	Day 15 decolonization defined as CFUs below the lower limit of quantitation
Phase 2a: Number of VRE Organisms Secreted in Stool at Day 15	Day 15	Quantitative (log10-transformed CFUs) assessment of VRE shedding in stool samples following treatment with VRELysin or placebo
Phase 2a: Number of VRE Organisms Secreted in Stool at Day 90	Day 90	Quantitative (log10-transformed CFUs) assessment of VRE shedding in stool samples following treatment with VRELysin or placebo
Phase 2a: Change in Number of VRE Organisms Secreted in Stool	up to Day 15	Change from baseline to Day 15 in log10-transformed colony forming units (CFUs) of VRE shedding in stool samples following treatment with VRELysin or placebo
Phase 2a: Number of VRE Organisms Secreted in Stool at Day 29	Day 29	Quantitative (log10-transformed CFUs) assessment of VRE shedding in stool samples following treatment with VRELysin or placebo

Trial Locations

Locations (1)

UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States