Actively Recruiting
Randomized Double-blind Placebo-controlled Study of HY-133 to Evaluate Safety, Tolerability, and Efficacy for Nasal Decolonization of Staphylococcus aureus
Led by University Hospital Tuebingen · Updated on 2024-12-06
52
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new method to remove Staphylococcus aureus bacteria from the nose using a product called HY-133, which is a recombinant chimeric bacteriophage endolysin. This clinical trial is a first-in-man, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and effectiveness of HY-133. The trial includes healthy adults who carry methicillin-susceptible S. aureus in their noses. Participants will receive either a low or high dose of HY-133 sprayed into both nostrils either once or five times in a single day. They will be randomly assigned in a 3:2 ratio to receive either the active treatment or a placebo, with both participants and investigators unaware of the assigned groups to prevent bias. The study also includes an extended phase to examine the effects of the treatment on the nasal microbiome. During the study, participants will be monitored for any adverse reactions or side effects from the time of treatment until the final visit on Day 15. Researchers will collect data on safety, tolerability, and response to the treatment. The total participation time is about 15 days, during which subjects will undergo assessments and procedures related to the treatment and its effects on nasal bacteria.
CONDITIONS
Brief Title
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older at the time of signing informed consent.
- Understand and voluntarily sign an informed consent document before any study procedures.
- Have nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA).
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during treatment until Day 15 of the study.
You will not qualify if you...
- Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA).
- Nasal trauma or presence of foreign bodies in the nose (e.g., piercings).
- Presence of significant health conditions such as diabetes or cardiovascular disease.
- Acute or chronic diseases of the nose, paranasal sinuses, or other parts of the respiratory tract.
- Runny nose due to other causes like allergies.
- Positive tests for HIV or hepatitis A, B, or C without proof of hepatitis B vaccination.
- Women who are pregnant or breastfeeding.
- History of allergy to the study drug or similar compounds.
- Participation in other clinical trials within 12 weeks prior to screening.
- Significant psychiatric, blood, lung, heart, liver, or kidney problems.
- Use of systemic antibiotics or intranasal eradication therapy within 12 weeks prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 15 days
Participants receive a single or multiple doses of either the study drug HY-133 or placebo for nasal decolonization of Staphylococcus aureus.
1 baseline visit and multiple follow-up visits up to Day 15
Trial Site Locations
Total: 2 locations
1
Department of Dermatology, University Hospital Tuebingen
Tübingen, Germany, D-72075
Actively Recruiting
2
Department of Dermatology
Tübingen, Germany
Actively Recruiting
Research Team
S
Sebastian Volc, PD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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