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First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
Sponsor: University Hospital Tuebingen
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.
Official title: A Randomized Double-blind Placebo-controlled First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of a Recombinant Chimeric Bacteriophage Endolysin HY-133 With an Extended Phase to Evaluate Effects of the Nasal Microbiome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2024-07-10
Completion Date
2026-07-01
Last Updated
2024-12-06
Healthy Volunteers
Yes
Conditions
Interventions
HY_133
A recombinant chimeric bacteriophage endolysin HY-133
Placebo
Placebo
Locations (2)
Department of Dermatology, University Hospital Tuebingen
Tübingen, Germany
Department of Dermatology
Tübingen, Germany