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Clinical Trials in the USA / NCT06750588
Starting soon Phase 1

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

NCT06750588 · tracked via the Priya Life Science USA tracker
Sponsor
Nterica Bio inc
Phase
Phase 1
Started
2025-11-05
Last updated
2025-08-17

Condition(s) studied

Alcohol-Associated Hepatitis

Investigational drug(s) / intervention(s)

bacteriophage preparation →Bacteriophage preparation →bacteriophage preparation →bacteriophage preparation →

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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

Primary outcome measure(s)

  • Frequency of adverse events — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
Southern California Research Center, inc Coronado California
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06750588 on ClinicalTrials.gov ↗ ← All trials in the USA