Clinical trial • Phase I • Infectious Disease
recombinant chimeric bacteriophage endolysin HY-133 for Nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)
Phase I trial of recombinant chimeric bacteriophage endolysin HY-133 for Nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA).
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)
- Trial Stage
- Phase I
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 31-01-2024
- First CTIS Authorization Date
- 28-03-2024
Trial design
Randomised, placebo (dose/schedule not specified)-controlled Phase I trial across 1 site in Germany.
- Randomised
- Yes
- Comparator
- Placebo (dose/schedule not specified)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 52
Eligibility
Recruits 52 Vulnerable population selected: true. No further details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected: true. No further details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 52
- Recruitment Window Months
- 13
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 52
Germany
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 628
- Number Of Sites
- 1
- Number Of Participants
- 52
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Sebastian Volc
- Principal Investigator Email
- sebastian.volc@med.uni-tuebingen.de
- Contact Person Name
- Sebastian Volc
- Contact Person Email
- sebastian.volc@med.uni-tuebingen.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Tuebingen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- HY-133
- Active Substance
- recombinant chimeric bacteriophage endolysin HY-133
- Modality
- Peptide/protein/enzyme
- First In Human
- Yes
Related trials
Other published trials that may interest you.
- Conditioned medium from a co-culture of M2-macrophages and fat-derived mesenchymal cells for Acute respiratory distress syndrome (ARDS) | SARS-CoV-2 infection | Influenza A infection | Influenza B infection | Respiratory syncytial virus (RSV) infection
- ACICLOVIR for Recurrent herpes labialis | Herpes simplex labialis
- AMIKACIN SULFATE for Sepsis | Neutropenia
- LENACAPAVIR, ISLATRAVIR for HIV-1 infection
- piperacillin sodium, tazobactam sodium for Extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae severe infection