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Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
Sponsor: Nterica Bio inc
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
Conditions
Interventions
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
Locations (1)
Southern California Research Center, inc
Coronado, California, United States