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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
bacteriophage preparation
DrugNTR-101 will be given orally to participants once daily for 7 days
Bacteriophage preparation
DrugNTR-101 will be given orally to participants once daily for 7 days
bacteriophage preparation
DrugNTR-101 will be given orally to participants twice daily for 7 days
bacteriophage preparation
DrugNTR-101 will be given orally to participants three times daily for 7 days
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: Cohort 1Active comparator 1 intervention
Group B: Cohort 2Active comparator 1 intervention
Group C: Cohort 3Active comparator 1 intervention
Group D: Cohort 4Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of adverse events
The number of adverse events (AEs) will be recorded.
Time frame
AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 352
Changes in liver function will be evaluated
ALT (alanine transaminase) and AST (aspartate aminotransferase) enzymes will be evaluated
Time frame
Assessments will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35Secondary outcomes
1
Preliminary assessment of NTR-101 efficacy and viability
Assessment of relative abundance of target pathogen and NTR-101 viability after oral administration
Time frame
Stool samples will be collected daily for 7 days, then weekly on days 14, 21, 28 and 35 to evaluate the presence of the target pathogen and NTR-101 viabilityOther outcomes
1
Evaluation of the effect of NTR-101 on various disease severity markers
changes from baseline in disease severity markers like Serum bilirubin, Serum sodium, Serum creatinine
Time frame
Samples for disease severity markers be collected daily for 7 days, then weekly on days 14, 21, 28 and 352
Susceptibility of recovered target bacteria to NTR-101 post-treatment
Stool samples will be collected for bacteria culture and assess for susceptibility to NTR-101
Time frame
Samples will be collected daily for 7 days, then weekly on days 14, 21, 28 and 35Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nterica Bio inc
Lead sponsor
Southern California Research Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: