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RECRUITING
NCT06290557
PHASE1

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

Sponsor: University Hospital Tuebingen

View on ClinicalTrials.gov

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.

Official title: A Randomized Double-blind Placebo-controlled First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of a Recombinant Chimeric Bacteriophage Endolysin HY-133 With an Extended Phase to Evaluate Effects of the Nasal Microbiome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-07-10

Completion Date

2026-07-01

Last Updated

2024-12-06

Healthy Volunteers

Yes

Interventions

DRUG

HY_133

A recombinant chimeric bacteriophage endolysin HY-133

DRUG

Placebo

Placebo

Locations (2)

Department of Dermatology, University Hospital Tuebingen

Tübingen, Germany

Department of Dermatology

Tübingen, Germany