Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, In Healthy and VRE-C… (NCT05715619) | Clinical Trial Compass
SuspendedPhase 1/2
Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysinâ„¢, In Healthy and VRE-Colonized Subjects
Stopped: Phase 2a paused due to funding limitations.
United States80 participantsStarted 2023-10-25
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
✕. Investigational research agents received within 30 days before first treatment.
✕. Pregnant or breastfeeding.
What they're measuring
1
Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions
Timeframe: Up to 36 days
2
Phase 2a: Number and Severity of Solicited and Unsolicited Adverse Reactions
. 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.