First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
- Conditions
- Staphylococcus Aureus
- Interventions
- Drug: HY_133Drug: Placebo
- Registration Number
- NCT06290557
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verum HY_133 Low Dose single application Low Dose multiple application High Dose single application high dose multiple application Placebo Placebo placebo
- Primary Outcome Measures
Name Time Method ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject baseline, pre-intervention/procedure/surgery, up to Day15 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Department of Dermatology, University Hospital Tuebingen
🇩🇪Tuebingen, Germany
Department of Dermatology
🇩🇪Tübingen, Germany