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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 12
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Nterica Bio incUpdated: Aug 17, 2025Locations: 1
Eligibility criteria

Diagnostic definition of acute alcohol-associated hepatitis based on well establ... [+6]

Participants considered at high risk for alcohol withdrawal according to the cli... [+9]