Staphylococcus AureusPhase 1HY-133NCT06290557
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
A Phase 1 study testing HY_133 in people with Staphylococcus Aureus, run by University Hospital Tuebingen at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- HY_133
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesGermany
- Study dates
- 10 Jul 2024to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Department of Dermatology, University Hospital Tuebingen
Tübingen, D-72075
Dr. Volc, +49 (0) 7071 29-83471, sebastian.volc@med.uni-tuebingen.de
Dr Volc
- Recruiting
Department of Dermatology
Tübingen
Dr. Volc, +49 (0) 7071 29-83471, sebastian.volc@med.uni-tuebingen.de
About this study
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
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
- Being tested
- HY_133, Placebo
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY_133Drug
A recombinant chimeric bacteriophage endolysin HY-133
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Low Dose single application Low Dose multiple application High Dose single application high dose multiple application Receives: Drug: HY_133 |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, pre-intervention/procedure/surgery, up to Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start10 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290557
- Sponsor's protocol ID
- HY-133
- Other IDs
- 2023-507737-17-00, 2023
- Acronym
- HY-133
- Status last verified
- Dec 2024
- First submitted
- 22 Feb 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06290557
- Acronym / sponsor ID
- HY-133 / HY-133
- Conditions
- Staphylococcus Aureus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: HY_133Low Dose single application Low Dose multiple application High Dose single application high dose multiple application |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HY_133A recombinant chimeric bacteriophage endolysin HY-133 | Drug | Verum |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HY_133 in people with Staphylococcus Aureus, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Volc, PD (07071 2926745, studienzentrum.immundermatologie@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.