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

Recruiting Phase 1 Interventional Study
Staphylococcus Aureus
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
52 (estimated)
Sponsor
University Hospital Tuebingen · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria * Must be ≥ 18 years at the time of signing the informedconsent. * Understand and voluntarily sign an informed consent document prior to any study related * assessments/procedures. * Nasal colonization with methicillin-susceptible S. aureus (MSSA) * Female Subject of childbearing…
Contacts

Sebastian Volc, PD

07071 2926745

studienzentrum.immundermatologie@med.uni-tuebingen.de

CONTACT