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

Staphylococcus Aureus Clinical Trial

— HY-133  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290557
• Other study ID #: 2023-507737-17-00
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: Sebastian Volc, PD
• Phone: 07071 2926745
• Email: studienzentrum.immundermatologie[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Staphylococcus Aureus

Intervention

Drug:
• HY_133
A recombinant chimeric bacteriophage endolysin HY-133
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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