Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
NCT ID: NCT06750588
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-11-05
2026-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Dose 1
bacteriophage preparation
NTR-101 will be given orally to participants once daily for 7 days
Cohort 2
Dose 2
Bacteriophage preparation
NTR-101 will be given orally to participants once daily for 7 days
Cohort 3
Dose 3
bacteriophage preparation
NTR-101 will be given orally to participants twice daily for 7 days
Cohort 4
Dose 4
bacteriophage preparation
NTR-101 will be given orally to participants three times daily for 7 days
Interventions
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bacteriophage preparation
NTR-101 will be given orally to participants once daily for 7 days
Bacteriophage preparation
NTR-101 will be given orally to participants once daily for 7 days
bacteriophage preparation
NTR-101 will be given orally to participants twice daily for 7 days
bacteriophage preparation
NTR-101 will be given orally to participants three times daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Southern California Research Center
OTHER
Nterica Bio inc
INDUSTRY
Responsible Party
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Principal Investigators
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Tarek Hassanein, MD
Role: PRINCIPAL_INVESTIGATOR
Southern California Research Center, inc
Locations
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Southern California Research Center, inc
Coronado, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Duan 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.
Other Identifiers
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NtericaAH-001
Identifier Type: -
Identifier Source: org_study_id
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