Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
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.
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. fae…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- 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: * Participa…
Interventions
- Drugbacteriophage preparation
NTR-101 will be given orally to participants once daily for 7 days
- DrugBacteriophage preparation
NTR-101 will be given orally to participants once daily for 7 days
- Drugbacteriophage preparation
NTR-101 will be given orally to participants twice daily for 7 days
- Drugbacteriophage preparation
NTR-101 will be given orally to participants three times daily for 7 days
Location
- Southern California Research Center, incCoronado, California