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

NCT05715619 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: ITX/VL-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vancomycin-Resistant Enterococcal Colonization

Keywords

bacteriophage; phage; VRE; Enterococcus; vancomycin

Outcome Measures

Primary Outcomes (2)

• Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions

  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

  Up to 36 days

• Phase 2a: Number and Severity of Solicited and Unsolicited Adverse Reactions

  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

  Up to 180 days

Secondary Outcomes (5)

• Phase 2a: Change in Number of VRE Organisms Secreted in Stool

  up to Day 15

• Phase 2a: Number of VRE Organisms Secreted in Stool at Day 15

  Day 15

• Phase 2a: Decolonization of VRE in Stool at Day 15

  Day 15

• Phase 2a: Number of VRE Organisms Secreted in Stool at Day 29

  Day 29

• Phase 2a: Number of VRE Organisms Secreted in Stool at Day 90

  Day 90

Other Outcomes (4)

• Phase 1: Number of VRE-specific Bacteriophage Shed in Blood and Stool

  up to Day 8

• Phase 1: Effect on Gut Microbiome Community States

  up to Day 8

• Phase 2a: Number of VRE-specific Bacteriophage Shed in Blood and Stool

  up to Day 29

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)

Other: Placebo

VRELysin™

ACTIVE COMPARATOR

Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)

Biological: VRELysin™

Interventions

Placebo OTHER

Placebo orally administered with sodium bicarbonate solution

Also known as: Phosphate Buffered Saline

Placebo

VRELysin™ BIOLOGICAL

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

VRELysin™

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible to participate in the Phase 1 segment of the study, each subject must fulfill ALL of the following criteria:
• Age 18 to 50 years old.
• Body mass index (BMI) of ≥19 kg/m2 to ≤40 kg/m2.
• Has the ability to understand the study procedures and risks involved with the study, voluntarily agrees to participate by giving written informed consent and is willing to adhere to dose and visit schedules. The subject must be able to read, understand, and complete questionnaires and memory aids.
• Agrees not to enroll in another study of an investigational research agent during the study, with the exception of potentially lifesaving or coronavirus disease of 2019 (COVID-19)-related experimental treatments.
• Good general health as shown by medical history, physical examination, and screening laboratory tests or clinical laboratory abnormalities per clinical judgment of Principal Investigator (PI).
• Agrees not to donate blood or blood products during participation in the study or for 30 days after completion of study participation.
• Has negative serology results for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
• Female subjects must have a negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at Screening and within 24 hours of initial treatment on Day 1.
• a. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records) are not required to undergo pregnancy testing.
• Female subjects of reproductive potential must agree to use adequate contraception, defined as consistent and correct use of an FDA-recommended contraceptive method or combination of methods in accordance with the product label. For example:
• Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide and another method, such as prescription hormonal contraceptive;
• Intrauterine device (IUD);
• Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch) subdermal, or intramuscular route used in combination with another method, such as barrier methods;
• Total abstinence;

You may not qualify if:

• To be eligible to participate in Phase 1, subjects must NOT fulfill ANY of the following criteria:
• Investigational research agents received within 30 days before first treatment.
• Pregnant or breastfeeding.
• Regular (no more than once a week) use of antidiarrheals, stool softeners, laxatives, antacids, or other agents to lower stomach acidity.
• Use of oral or intravenous antimicrobials within 2 weeks of study start or planned use during active study phase. Topical treatments are allowed.
• Proton pump inhibitors, H2 blockers or antacids within 48 hours prior to dosing or planned use during active study phase.
• Abnormal bowel patterns, defined by \<3 stools per week or \>2 stools per day on average over the past 6 months.
• History of diarrhea in the 7 days prior to treatment. Outpatient diarrhea is defined as ≥ 3 unformed (Grade 3 or greater) loose stools in 24 hours.
• Use of oral supplemental probiotics in the form of pills or tablets within 2 weeks of study start or planned use during active study phase.
• History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up).
• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes, but is not limited to:
• Any contraindication to repeated blood draws;
• A condition or process for which signs or symptoms could be confused with reactions to treatment;
• Any of the following in the past 10 years: Crohn's disease, ulcerative colitis, irritable bowel disease, celiac disease, stomach, or intestinal ulcers, or 2 or more episodes of inflammatory arthritis (joint pain and swelling);
• Bacterial infection at time of enrollment;

Sponsors & Collaborators

• Intralytix, Inc.: lead

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Minh-Hong Nguyen, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 8, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)