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

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called HY-133, which aims to help eliminate a type of bacteria called Staphylococcus aureus from the nose. The treatment involves spraying HY-133 into both nostrils of healthy adults either once or five times in a single day. The trial is designed to ensure fairness, meaning that participants will be randomly assigned to receive either the actual treatment or a placebo (which looks the same but doesn't contain the active treatment). Both participants and researchers will not know which group they are in to reduce bias in the results.

To be eligible for this trial, participants must be at least 18 years old, be colonized with a specific form of Staphylococcus aureus that is not resistant to certain antibiotics, and agree to use effective birth control if they are able to conceive. Those with certain health conditions, such as significant respiratory or nose-related diseases, or who are pregnant or breastfeeding, will not be able to participate. Throughout the study, participants will be monitored for safety and how well the treatment works, helping researchers understand if HY-133 is a good option for treating nasal colonization by this bacteria.

Gender

ALL

Eligibility criteria

• • 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.