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

Staphylococcus Aureus Clinical Trial

Official title:
A Randomized Double-blind Placebo-controlled First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of a Recombinant Chimeric Bacteriophage Endolysin HY-133 With an Extended Phase to Evaluate Effects of the Nasal Microbiome

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06290557
Study type Interventional
Source University Hospital Tuebingen
Contact Sebastian Volc, PD
Phone 07071 2926745
Email studienzentrum.immundermatologie@med.uni-tuebingen.de
Status Not yet recruiting
Phase Phase 1
Start date July 1, 2024
Completion date July 1, 2026
View Details
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