RecruitingPhase 1NCT06290557

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

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


Sponsor

University Hospital Tuebingen

Enrollment

52 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HY_133 and a drug called Placebo for people with staphylococcus aureus. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHY_133

A recombinant chimeric bacteriophage endolysin HY-133

DRUGPlacebo

Placebo


Locations(2)

Department of Dermatology, University Hospital Tuebingen

Tübingen, Germany

Department of Dermatology

Tübingen, Germany

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NCT06290557


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