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

Part of paid clinical trials in Coronado, California.

Sponsor
Nterica Bio inc
Study ID
NCT06750588
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Alcohol-Associated Hepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • bacteriophage preparation — DRUG
    NTR-101 will be given orally to participants once daily for 7 days
  • Bacteriophage preparation — DRUG
    NTR-101 will be given orally to participants once daily for 7 days
  • bacteriophage preparation — DRUG
    NTR-101 will be given orally to participants twice daily for 7 days
  • bacteriophage preparation — DRUG
    NTR-101 will be given orally to participants three times daily for 7 days

Study Details

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.

Key Dates

Start date
Nov 5, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1
    Dose 1
  • Active Comparator: Cohort 2
    Dose 2
  • Active Comparator: Cohort 3
    Dose 3
  • Active Comparator: Cohort 4
    Dose 4

Primary Outcome Measure

Frequency of adverse events [ Time Frame: AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southern California Research Center, incCoronadoCalifornia92118
Kasey Seyer
[email protected]
619-522-0330
Tarek Hassanein, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Coronado, CA

By research site
Southern California Research Center, inc· Coronado, CA

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