NCT06750588

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nterica Bio inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Alcohol-associated hepatitis (AH) is a severe inflammatory liver disease that can progress to liver failure, with high morbidity and mortality rates. Emerging studies indicate a significant role of gut-derived pathogens, particularly Enterococcus faecalis (E faecalis), in exacerbating liver damage through bacterial translocation and the release of toxins. Cytolysin-positive E. faecalis strains exhibit high virulence and resistance to standard antibiotics. NTR-101 is a product developed for oral delivery and composed of natural bacteriophages that specifically target cytolysin-positive E. faecalis. The targeted activity of NTR-101 against E. faecalis in AH patients has the potential to address the underlying bacterial trigger, offering a novel approach to mitigate liver inflammation and reduce disease progression. For patients who do not respond to traditional treatments like corticosteroids or experience reduced antibiotic therapy efficacy, NTR-101 represents a novel, targeted approach that leverages bacteriophages' specificity for bacterial strains in this target population, offering a potential alternative or complement to traditional antibiotics.

Conditions

• Alcohol-Associated Hepatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2024-12-27
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study