Clinical study
HY-133
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
| Status | Recruiting |
|---|---|
| Type | Adjacent product trial |
| Countries | Germany |
| Conditions studied | Staphylococcus Aureus |
| Study years | 2024–2026 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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.
Study description
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.
Study registrations
| ClinicalTrials.gov | NCT06290557 |
|---|---|
| CTIS | 2023-507737-17-00 |
Recorded study locations (2)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Department of Dermatology, University Hospital Tuebingen
Tübingen, Germany
Recorded site status: Recruiting. Study location source ↗
Department of Dermatology
Tübingen, Germany
Recorded site status: Recruiting. Study location source ↗
Notes from the source review
- Recombinant endolysin HY133, not live phage. CTIS2023-507737-17-00 confirms ongoing,recruiting Germany. Planned completion date has passed while registry status remains nonterminal; recheck with site.
- Recombinant phage endolysin; adjacent product, not whole-phage treatment.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct06290557 |
|---|