MedTrace Logo

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

NCT06290557 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-12-06

No results posted yet for this study

Summary

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.

Conditions

  • Staphylococcus Aureus

Interventions

DRUG

HY_133

A recombinant chimeric bacteriophage endolysin HY-133

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-07-01
Completion
2026-07-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290557 on ClinicalTrials.gov