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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Staphylococcus Aureus
• Intervention / Treatment: Drug: Placebo; Drug: HY_133

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sebastian Volc, PD; Phone Number: 07071 2926745; Email: studienzentrum.immundermatologie@med.uni-tuebingen.de

Study Locations

• Germany
  • Tuebingen, Germany, D-72075
    • Recruiting
    • Department of Dermatology, University Hospital Tuebingen
    • Contact: Dr. Volc; Phone Number: +49 (0) 7071 29-83471; Email: sebastian.volc@med.uni-tuebingen.de
    • Principal Investigator: Dr Volc
  • Tübingen, Germany
    • Recruiting
    • Department of Dermatology
    • Contact: Dr. Volc; Phone Number: +49 (0) 7071 29-83471; Email: sebastian.volc@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo	Drug: Placebo; Placebo
Experimental: Verum; Low Dose single application Low Dose multiple application High Dose single application high dose multiple application	Drug: HY_133; A recombinant chimeric bacteriophage endolysin HY-133

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject	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	baseline, pre-intervention/procedure/surgery, up to Day15

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HY-133; 2023-507737-17-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No