drugset / Trial / NCT06290557

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

NCT06290557 ↗

Phase 1 Recruiting 52 enrolled University Hospital Tuebingen
RandomizedParallel-groupQuadruple-blindOther

Summary

In this clinical trial we will test a new approach for decolonization of S. aureus. As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned.

Timeline

Start
2024-07-10
Primary completion
2025-07-01
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HY-133 Protein / enzyme biologic — Intranasal