Actively Recruiting
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
Led by University Hospital Tuebingen · Updated on 2024-12-06
52
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 informed consent before any study procedures
- Nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during treatment until Day 15
You will not qualify if you...
- Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA)
- Nasal trauma including foreign bodies like piercings
- Presence of significant illnesses such as diabetes or cardiovascular disease
- Acute or chronic diseases of the nose, paranasal sinuses, or other respiratory tract parts
- Runny nose from other causes such as allergies
- Positive HIV, hepatitis A, B, or C infection; if positive for hepatitis B surface antigen, vaccination proof is required
- Pregnant or breastfeeding women
- History of allergy to the investigational product or similar drugs
- Participation in other clinical trials within 12 weeks before screening
- Significant psychiatric, blood, lung, heart, liver, or kidney problems
- Systemic antibiotic use within 12 weeks before screening
- Intranasal eradication therapy within 12 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here