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.
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