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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
52
Department of Dermatology, University Hospital Tuebingen
Tübingen, Germany
RECRUITINGDepartment of Dermatology
Tübingen, Germany
RECRUITINGADRs/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
Time frame: baseline, pre-intervention/procedure/surgery, up to Day15
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