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NCT06290557: HY-133
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
Phase 1 trial testing HY_133 in Staphylococcus Aureus in 52 participants. Currently enrolling.
1 July 2025
Quick facts
| Lead sponsor | University Hospital Tuebingen |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 52 |
| Start date | 10 July 2024 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 July 2026 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- HY_133 — full drug profile →
- Placebo
Conditions studied
- Staphylococcus Aureus — all drugs for Staphylococcus Aureus →
Sponsor
University Hospital Tuebingen
Who can join
18 and older, any sex, with Staphylococcus Aureus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phage and Endolysin Therapy Against Antibiotics Resistant Bacteria: From Bench to Bedside.
Taati Moghadam M, Mohebi S, Sheikhi R, Hasannejad-Bibalan M, et al · · 2025 · cited 4× · PMID 40661138 · DOI 10.1002/mco2.70280 -
Clinical implementation of endolysins targeting gram-positive bacteria points toward a combination strategy with standard-of-care antibiotics: a selective review.
Vander Elst N. · · 2026 · cited 1× · PMID 41514460 · DOI 10.1186/s40001-025-03655-4 -
Limitation of the Lytic Effect of Bacteriophages on <i>Salmonella</i> and Other Enteric Bacterial Pathogens and Approaches to Overcome.
Tung CW, Julianingsih D, Phan A, Canagarajah C, et al · · 2025 · cited 1× · PMID 40405891 · DOI 10.1155/ijm/5936070 -
[Phage endolysins-a novel class of antibacterial agents with a wide range of applications].
Idelevich EA, Becker K. · · 2025 · PMID 40328935 · DOI 10.1007/s00103-025-04059-9
Verify or expand the search:
- PubMed search for NCT06290557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other University Hospital Tuebingen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06290557 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Tuebingen
- Last refreshed: 6 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06290557.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing