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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Vancomycin-Resistant Enterococcal Colonization
- Sponsor
- Intralytix, Inc.
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Phase 2a: Number and Severity of Solicited and Unsolicited Adverse Reactions
- Status
- Suspended
- Last Updated
- 18 days ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •PHASE 1 INCLUSION CRITERIA:
- •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/m
- •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
Exclusion Criteria
- •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).
Arms & Interventions
Placebo
Dose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)
Intervention: Placebo
VRELysin™
Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)
Intervention: VRELysin™
Outcomes
Primary Outcomes
Phase 2a: Number and Severity of Solicited and Unsolicited Adverse Reactions
Time Frame: 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
Time Frame: 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 Outcomes
- Phase 2a: Decolonization of VRE in Stool at Day 15(Day 15)
- Phase 2a: Number of VRE Organisms Secreted in Stool at Day 15(Day 15)
- Phase 2a: Number of VRE Organisms Secreted in Stool at Day 90(Day 90)
- 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 29(Day 29)