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.
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.