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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507737-17-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Low Dose single application Low Dose multiple application High Dose single application high dose multiple application |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HY_133 | Drug | A recombinant chimeric bacteriophage endolysin HY-133 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, pre-intervention/procedure/surgery, up to Day15 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Volc, PD | Contact | 07071 2926745 | studienzentrum.immundermatologie@med.uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, University Hospital Tuebingen | Recruiting | Tübingen | D-72075 | Germany |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Placebo |
| Drug |
Placebo |
|
| Department of Dermatology | Recruiting | Tübingen | Germany |
|