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.
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)
Nasal colonization with methicillin-resistant S. aureus (MRSA)
Nasal traumata including nose penetrating foreign bodies (e.g. piercings)
Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease
Acute or known chronic diseases of the nose or the paranasal sinuses
Parallel
HY_133
DrugA recombinant chimeric bacteriophage endolysin HY-133
Placebo
DrugPlacebo
ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject
The primary objective of this trial is to evaluate the safety of the HY-133. Fort the primary objective the nature, frequency, and severity of AEs and/or SAEs occurring in the study are recorded as follows: ADRs/AEs/SAEs occurring from the time of application until the final study visit (D15) for each subject A DLT is defined as any AE of Grade 4 or above related to the IMP
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