Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis

NCT06750588 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NtericaAH-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcohol-Associated Hepatitis

Keywords

bacteriophages; alcohol-associated hepatitis; NTR-101; bacteriophage therapy

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events

  The number of adverse events (AEs) will be recorded.

  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

  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

  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

Other Outcomes (2)

• Evaluation of the effect of NTR-101 on various disease severity markers

  Samples for disease severity markers be collected daily for 7 days, then weekly on days 14, 21, 28 and 35

• Susceptibility of recovered target bacteria to NTR-101 post-treatment

  Samples will be collected daily for 7 days, then weekly on days 14, 21, 28 and 35

Study Arms (4)

Cohort 1

ACTIVE COMPARATOR

Dose 1

Drug: bacteriophage preparation

Cohort 2

ACTIVE COMPARATOR

Dose 2

Drug: Bacteriophage preparation

Cohort 3

ACTIVE COMPARATOR

Dose 3

Drug: bacteriophage preparation

Cohort 4

ACTIVE COMPARATOR

Dose 4

Drug: bacteriophage preparation

Interventions

bacteriophage preparation DRUG

NTR-101 will be given orally to participants once daily for 7 days

Cohort 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nterica Bio inc: lead
• Southern California Research Center: collaborator

Study Sites (1)

Southern California Research Center, inc

Coronado, California, 92118, United States

Location

Related Publications (2)

• 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.

  PMID: 35336897 BACKGROUND

• 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.

  PMID: 31723265 BACKGROUND

Study Officials

• Tarek Hassanein, MD

  Southern California Research Center, inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+61 (0) 411821040; info@phageconsulting.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 27, 2024
• Study Start: November 5, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)