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NOT YET RECRUITING
NCT06750588
PHASE1

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

Sponsor: Nterica Bio inc

View on ClinicalTrials.gov

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.

Official title: Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-11-05

Completion Date

2026-06

Last Updated

2025-08-17

Healthy Volunteers

No

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

Locations (1)

Southern California Research Center, inc

Coronado, California, United States