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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

Recruiting now Phase 1 Last updated 6 December 2024
What this trial tests

Phase 1 trial testing HY_133 in Staphylococcus Aureus in 52 participants. Currently enrolling.

Timeline
10 July 2024
Primary endpoint
1 July 2025
1 July 2026

Quick facts

Lead sponsorUniversity Hospital Tuebingen
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment52
Start date10 July 2024
Primary completion1 July 2025
Estimated completion1 July 2026
Sites2 locations across Germany

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. [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:

Other recruiting trials for Staphylococcus Aureus

Currently open trials in the same condition.

Other University Hospital Tuebingen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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