MedTrace Logo

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

NCT06750588 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-17

No results posted yet for this study

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

Interventions

DRUG

bacteriophage preparation

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

DRUG

Bacteriophage preparation

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

DRUG

bacteriophage preparation

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

DRUG

bacteriophage preparation

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

Sponsors & Collaborators

  • Southern California Research Center

    collaborator OTHER

  • Nterica Bio inc

    lead INDUSTRY

Principal Investigators

  • Tarek Hassanein, MD · Southern California Research Center, inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2026-04-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750588 on ClinicalTrials.gov