Clinical Trial

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

Study acronym: HY-133
Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated December 6, 2024 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-01; most recent amendment 2024-12-03.
Status change: Not Yet Recruiting → Recruiting 2024-12-03
Trial Details
NCT Number NCT06290557
Lead Sponsor University Hospital Tuebingen
Conditions Staphylococcus Aureus
Enrollment 52 participants
Start Date 2024-07-10
Primary Completion 2025-07-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-06