Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
ConditionAlcohol-Associated Hepatitis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNterica Bio inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Participants considered at high risk for alcohol withdrawal according to the clinical institute withdrawal assessment (CIWA-Ar) protocol
Participants taking systemic corticosteroids for a specified duration
Platelet count below specified ranges
INR and Serum creatinine levels above specified ranges
Trial design
Treatments tested in this trial
- bacteriophage preparation
- Bacteriophage preparation
- bacteriophage preparation
- bacteriophage preparation
Treatment groups
12 Participants
are divided into 4 treatment groupsSponsors and collaborators
Nterica Bio inc
Lead sponsor
Southern California Research Center
Collaborator
Source ClinicalTrials.gov