Testing a new treatment for Staphylococcus Aureus decolonization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, and efficacy of a novel recombinant chimeric bacteriophage endolysin, HY-133, for decolonizing Staphylococcus Aureus in healthy subjects. Participants will receive either a single dose or multiple doses of the treatment, administered as a nasal spray, with a randomized, double-blind, placebo-controlled design to ensure unbiased results. The study aims to determine the effectiveness of HY-133 in reducing nasal colonization of methicillin-susceptible S. aureus (MSSA).

Why it matters

Who can join: the full rules

Inclusion Criteria

* Must be ≥ 18 years at the time of signing the informedconsent.
* Understand and voluntarily sign an informed consent document prior to any study related
* assessments/procedures.
* Nasal colonization with methicillin-susceptible S. aureus (MSSA)
* Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15

Exclusion Criteria

* Nasal colonization with methicillin-resistant S. aureus (MRSA)
* Nasal traumata including nose penetrating foreign bodies (e.g. piercings)
* Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease
* Acute or known chronic diseases of the nose or the paranasal sinuses
* Acute or known chronic diseases of other parts of the respiratory tract
* Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
* Women during pregnancy and lactation.
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening.
* Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
* Systemic antibiotic treatment in the 12 weeks prior to screening.
* Intranasal eradication therapy in the 12 weeks prior to screening.

Where it's running

• Department of Dermatology, University Hospital Tuebingen
  Tübingen, Germany Recruiting
• Department of Dermatology
  Tübingen, Germany Recruiting

Study contacts

• Study coordinator: Sebastian Volc, PD
• Email: studienzentrum.immundermatologie@med.uni-tuebingen.de
• Phone: 07071 2926745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.