Study to Test Safety and Effectiveness of Nasal Spray HY-133 for Staphylococcus Aureus in Adults

What this Trial Is About

Researchers are evaluating a new method to remove Staphylococcus aureus bacteria from the nose using a product called HY-133, which is a recombinant chimeric bacteriophage endolysin. This clinical trial is a first-in-man, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and effectiveness of HY-133. The trial includes healthy adults who carry methicillin-susceptible S. aureus in their noses. Participants will receive either a low or high dose of HY-133 sprayed into both nostrils either once or five times in a single day. They will be randomly assigned in a 32 ratio to receive either the active treatment or a placebo, with both participants and investigators unaware of the assigned groups to prevent bias. The study also includes an extended phase to examine the effects of the treatment on the nasal microbiome. During the study, participants will be monitored for any adverse reactions or side effects from the time of treatment until the final visit on Day 15. Researchers will collect data on safety, tolerability, and response to the treatment. The total participation time is about 15 days, during which subjects will undergo assessments and procedures related to the treatment and its effects on nasal bacteria.

First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133