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Tests treatment safety and results for Staphylococcus Aureus
Official title First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
ClinicalTrials.gov ID: NCT06290557
What this study is testing
What is HY_133?
HY_133 is an investigational medicine, being studied as a potential treatment for staphylococcus aureus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this clinical trial we will test a new approach for decolonization of S. aureus.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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 people with female partner of childbearing potential1 is willing to use highly effective...
You likely can't join if
- 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...
See the full eligibility 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 people with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15
- 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...
- 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...
- Systemic antibiotic treatment in the 12 weeks prior to screening.
- Intranasal eradication therapy in the 12 weeks prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.