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NCT Number: NCT06290557

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Dermatology, Tübingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be ≥ 18 years at the time of signing the informedconsent.
  • Understand and voluntarily sign an informed consent document prior to any study related
  • assessments/procedures.
  • Nasal colonization with methicillin-susceptible S. aureus (MSSA)
  • Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15

Exclusion criteria

  • Nasal colonization with methicillin-resistant S. aureus (MRSA)
  • Nasal traumata including nose penetrating foreign bodies (e.g. piercings)
  • Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease
  • Acute or known chronic diseases of the nose or the paranasal sinuses
  • Acute or known chronic diseases of other parts of the respiratory tract
  • Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
  • Women during pregnancy and lactation.
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening.
  • Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
  • Systemic antibiotic treatment in the 12 weeks prior to screening.
  • Intranasal eradication therapy in the 12 weeks prior to screening.

Treatment and study plan

HY_133

Drug

A recombinant chimeric bacteriophage endolysin HY-133

Placebo

Drug

Placebo

Primary outcomes

  1. ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject

    Time frame: baseline, pre-intervention/procedure/surgery, up to Day15

    The primary objective of this trial is to evaluate the safety of the HY-133. Fort the primary objective the nature, frequency, and severity of AEs and/or SAEs occurring in the study are recorded as follows: ADRs/AEs/SAEs occurring from the time of application until the final study visit (D15) for each subject A DLT is defined as any AE of Grade 4 or above related to the IMP

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Volc, PD

CONTACT

[email protected]

07071 2926745

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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

Acronym: HY-133

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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