First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HY_133
  • Placebo

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators