Alcohol-Associated HepatitisPhase 1PhoenixAHNCT06750588
Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
A Phase 1 study testing bacteriophage preparation in people with Alcohol-Associated Hepatitis, run by Nterica Bio inc at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis (AH). The drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol-Associated Hepatitis
- What is being tested?
- bacteriophage preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic definition of acute alcohol-associated hepatitis based on well established standard disease markers
- Able to provide written informed consent (either from patient or patient's legally authorized representative)
- Male and female patients aged ≥18 years and ≤ 70 years of age
- BMI ≥ 20 to ≤ 40 kg/m2
- Enterococcus faecalis testing
- Susceptibility to NTR-101
- Women of child-bearing potential and male patients must agree to use a medically acceptable method of contraception/ birth control throughout the study duration.
Who cannot join
- Participants considered at high risk for alcohol withdrawal according to the clinical institute withdrawal assessment (CIWA-Ar) protocol
- Participants taking systemic corticosteroids for a specified duration
- Platelet count below specified ranges
- INR and Serum creatinine levels above specified ranges
- Active bacterial or viral infections
- Other or concomitant cause(s) of liver disease as a result of other conditions
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- Co-infection with HIV
- Positive urine drug screen
- Any significant systemic or major illness other than liver disease that, in the opinion of the investigator, would preclude the patient from participating in and completing the study or might complicated or exacerbated by the proposed treatments or might confound assessment of investigational product
- If female, known pregnancy, or has a positive serum pregnancy test, or lactating/ breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Southern California Research Center, inc
Coronado, California, 92118
Kasey Seyer, 619-522-0330, recruitment@researchscrc.com
Tarek Hassanein, MD
About this study
Official title: Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis (AH).
The drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role.
Read more
The main questions it aims to answer are:
Are multiple doses of NTR-101 in participants with acute AH safe and well tolerated? What medical problems do participants have when taking NTR-101? Researchers will administer the drug and monitor participants in an inpatient center.
Participants will:
Be administered multiple ascending dose frequencies of NTR-101 every day for 7 days.
Stay in the clinic for 9 days (7 days of treatment) and present to clinic once every week for checkups and tests for 35 days.
Keep a diary of their symptoms until the checkups and tests are completed.
Read the detailed description
Alcohol-associated hepatitis (AH) is a severe inflammatory liver disease that can progress to liver failure, with high morbidity and mortality rates. Emerging studies indicate a significant role of gut-derived pathogens, particularly Enterococcus faecalis (E faecalis), in exacerbating liver damage through bacterial translocation and the release of toxins.
Cytolysin-positive E. faecalis strains exhibit high virulence and resistance to standard antibiotics.
NTR-101 is a product developed for oral delivery and composed of natural bacteriophages that specifically target cytolysin-positive E. faecalis.
The targeted activity of NTR-101 against E. faecalis in AH patients has the potential to address the underlying bacterial trigger, offering a novel approach to mitigate liver inflammation and reduce disease progression. For patients who do not respond to traditional treatments like corticosteroids or experience reduced antibiotic therapy efficacy, NTR-101 represents a novel, targeted approach that leverages bacteriophages' specificity for bacterial strains in this target population, offering a potential alternative or complement to traditional antibiotics.
- Conditions
- Alcohol-Associated Hepatitis
- Being tested
- bacteriophage preparation
- Keywords
- bacteriophages, alcohol-associated hepatitis, NTR-101, bacteriophage therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacteriophage preparationDrug
NTR-101 will be given orally to participants once daily for 7 days
Bacteriophage preparationDrug
NTR-101 will be given orally to participants once daily for 7 days
bacteriophage preparationDrug
NTR-101 will be given orally to participants twice daily for 7 days
bacteriophage preparationDrug
NTR-101 will be given orally to participants three times daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Dose 1 Receives: Drug: bacteriophage preparation |
| Cohort 2 | Active comparator | Dose 2 Receives: Drug: Bacteriophage preparation |
| Cohort 3 | Active comparator | Dose 3 Receives: Drug: bacteriophage preparation |
| Cohort 4 | Active comparator | Dose 4 Receives: Drug: bacteriophage preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
The number of adverse events (AEs) will be recorded.
Measured: AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
Changes in liver function will be evaluated
ALT (alanine transaminase) and AST (aspartate aminotransferase) enzymes will be evaluated
Measured: Assessments will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
Secondary outcomes (1)
Preliminary assessment of NTR-101 efficacy and viability
Assessment of relative abundance of target pathogen and NTR-101 viability after oral administration
Measured: Stool samples will be collected daily for 7 days, then weekly on days 14, 21, 28 and 35 to evaluate the presence of the target pathogen and NTR-101 viability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start5 Nov 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Associated HepatitisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nterica Bio inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern California Research Center
- Responsible party
- Sponsor
- Investigators
- Tarek Hassanein, MD, Principal investigator, Southern California Research Center, inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750588
- Sponsor's protocol ID
- NtericaAH-001
- Acronym
- PhoenixAH
- Status last verified
- Aug 2025
- First submitted
- 29 Nov 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study IPD may not be shared for three key reasons. 1. The study is primarily designed to assess the safety and tolerability of a drug in a small group of participants, making the sample size too small to ensure participant anonymity. Revealing individual data could risk participant privacy, especially as the study is open label. 2. This study is also aimed at collective sensitive information regarding pharmacokinetics, dosing levels, and early safety signals, which are critical to a sponsor's competitive advantage. Sharing this data prematurely could impact intellectual property or strategic positioning at this early stage of development. 3. This study is not aimed to demonstrating efficacy but rather focus on basic safety and dose-ranging, making the data limited in broader scientific value compared to later-phase trials.
Publications
Mendes BG, Duan Y, Schnabl B. Immune Response of an Oral Enterococcus faecalis Phage Cocktail in a Mouse Model of Ethanol-Induced Liver Disease. Viruses. 2022 Feb 27;14(3):490. doi: 10.3390/v14030490.
PubMed 35336897Duan Y, Llorente C, Lang S, Brandl K, Chu H, Jiang L, White RC, Clarke TH, Nguyen K, Torralba M, Shao Y, Liu J, Hernandez-Morales A, Lessor L, Rahman IR, Miyamoto Y, Ly M, Gao B, Sun W, Kiesel R, Hutmacher F, Lee S, Ventura-Cots M, Bosques-Padilla F, Verna EC, Abraldes JG, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross DL, Ho SB, Louvet A, Lucey MR, Mathurin P, Garcia-Tsao G, Bataller R, Tu XM, Eckmann L, van der Donk WA, Young R, Lawley TD, Starkel P, Pride D, Fouts DE, Schnabl B. Bacteriophage targeting of gut bacterium attenuates alcoholic liver disease. Nature. 2019 Nov;575(7783):505-511. doi: 10.1038/s41586-019-1742-x. Epub 2019 Nov 13.
PubMed 31723265
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
- ClinicalTrials.gov ID
- NCT06750588
- Acronym / sponsor ID
- PhoenixAH / NtericaAH-001
- Conditions
- Alcohol-Associated Hepatitis
- Keywords
- bacteriophages, alcohol-associated hepatitis, NTR-101, bacteriophage therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nterica Bio incIndustry (pharma, biotech, devices)
- Collaborators
- Southern California Research Center
- Study start
- 5 Nov 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Dec 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.
The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis (AH).
The drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role.
The main questions it aims to answer are:
Are multiple doses of NTR-101 in participants with acute AH safe and well tolerated? What medical problems do participants have when taking NTR-101? Researchers will administer the drug and monitor participants in an inpatient center.
Participants will:
Be administered multiple ascending dose frequencies of NTR-101 every day for 7 days.
Stay in the clinic for 9 days (7 days of treatment) and present to clinic once every week for checkups and tests for 35 days.
Keep a diary of their symptoms until the checkups and tests are completed.
Detailed description
Alcohol-associated hepatitis (AH) is a severe inflammatory liver disease that can progress to liver failure, with high morbidity and mortality rates. Emerging studies indicate a significant role of gut-derived pathogens, particularly Enterococcus faecalis (E faecalis), in exacerbating liver damage through bacterial translocation and the release of toxins.
Cytolysin-positive E. faecalis strains exhibit high virulence and resistance to standard antibiotics.
NTR-101 is a product developed for oral delivery and composed of natural bacteriophages that specifically target cytolysin-positive E. faecalis.
The targeted activity of NTR-101 against E. faecalis in AH patients has the potential to address the underlying bacterial trigger, offering a novel approach to mitigate liver inflammation and reduce disease progression. For patients who do not respond to traditional treatments like corticosteroids or experience reduced antibiotic therapy efficacy, NTR-101 represents a novel, targeted approach that leverages bacteriophages' specificity for bacterial strains in this target population, offering a potential alternative or complement to traditional antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: bacteriophage preparationDose 1 |
| Cohort 2 | Active comparator | Drug: Bacteriophage preparationDose 2 |
| Cohort 3 | Active comparator | Drug: bacteriophage preparationDose 3 |
| Cohort 4 | Active comparator | Drug: bacteriophage preparationDose 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnostic definition of acute alcohol-associated hepatitis based on well established standard disease markers
- Able to provide written informed consent (either from patient or patient's legally authorized representative)
- Male and female patients aged ≥18 years and ≤ 70 years of age
- BMI ≥ 20 to ≤ 40 kg/m2
- Enterococcus faecalis testing
Key exclusion criteria (10 listed)
- Participants considered at high risk for alcohol withdrawal according to the clinical institute withdrawal assessment (CIWA-Ar) protocol
- Participants taking systemic corticosteroids for a specified duration
- Platelet count below specified ranges
- INR and Serum creatinine levels above specified ranges
- Active bacterial or viral infections
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 |
|---|---|---|
| bacteriophage preparationNTR-101 will be given orally to participants once daily for 7 days | Drug | Cohort 1 |
| Bacteriophage preparationNTR-101 will be given orally to participants once daily for 7 days | Drug | Cohort 2 |
| bacteriophage preparationNTR-101 will be given orally to participants twice daily for 7 days | Drug | Cohort 3 |
| bacteriophage preparationNTR-101 will be given orally to participants three times daily for 7 days | Drug | Cohort 4 |
Primary outcome
Frequency of adverse events
Time frame: AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
The number of adverse events (AEs) will be recorded.
Changes in liver function will be evaluated
Time frame: Assessments will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
ALT (alanine transaminase) and AST (aspartate aminotransferase) enzymes will be evaluated
1 secondary outcome
Preliminary assessment of NTR-101 efficacy and viability
Time frame: Stool samples will be collected daily for 7 days, then weekly on days 14, 21, 28 and 35 to evaluate the presence of the target pathogen and NTR-101 viability
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 17 Aug 2025.
- Background: PubMed 35336897Mendes BG, Duan Y, Schnabl B. Immune Response of an Oral Enterococcus faecalis Phage Cocktail in a Mouse Model of Ethanol-Induced Liver Disease. Viruses. 2022 Feb 27;14(3):490. doi: 10.3390/v14030490.
- Background: PubMed 31723265Duan Y, Llorente C, Lang S, Brandl K, Chu H, Jiang L, White RC, Clarke TH, Nguyen K, Torralba M, Shao Y, Liu J, Hernandez-Morales A, Lessor L, Rahman IR, Miyamoto Y, Ly M, Gao B, Sun W, Kiesel R, Hutmacher F, Lee S, Ventura-Cots M, Bosques-Padilla F, Verna EC, Abraldes JG, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross DL, Ho SB, Louvet A, Lucey MR, Mathurin P, Garcia-Tsao G, Bataller R, Tu XM, Eckmann L, van der Donk WA, Young R, Lawley TD, Starkel P, Pride D, Fouts DE, Schnabl B. Bacteriophage targeting of gut bacterium attenuates alcoholic liver disease. Nature. 2019 Nov;575(7783):505-511. doi: 10.1038/s41586-019-1742-x. Epub 2019 Nov 13.
- Individual participant dataSharing planned: Undecided. The study IPD may not be shared for three key reasons. 1. The study is primarily designed to assess the safety and tolerability of a drug in a small group of participants, making the sample size too small to ensure participant anonymity. Revealing individual data could risk participant privacy, especially as the study is open label. 2. This study is also aimed at collective sensitive information regarding pharmacokinetics, dosing levels, and early safety signals, which are critical to a sponsor's competitive advantage. Sharing this data prematurely could impact intellectual property or strategic positioning at this early stage of development. 3. This study is not aimed to demonstrating efficacy but rather focus on basic safety and dose-ranging, making the data limited in broader scientific value compared to later-phase trials.
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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.
Tarek Hassanein, MD principal investigator
Southern California Research Center, inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bacteriophage preparation in people with Alcohol-Associated Hepatitis, run by Nterica Bio inc at 1 site in United States.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 Project Manager (+61 (0) 411821040, info@phageconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (time frame: AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750588, which also lists 2 linked publications.
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 17 Aug 2025.