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

Study acronym: HY-133
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 6, 2024 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 1, 2024 to Jul 10, 2024
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06290557
Lead Sponsor University Hospital Tuebingen
Conditions
(from sponsor)		 Staphylococcus Aureus
Related terms Staphylococcal Infections
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov