NCT06750588: PhoenixAH

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

Not yet recruiting Phase 1 Last updated 13 August 2025

What this trial tests

Phase 1 trial testing bacteriophage preparation in Alcohol-Associated Hepatitis in 12 participants. Not yet recruiting.

Timeline

5 November 2025

Primary endpoint
1 April 2026

1 June 2026

Quick facts

Lead sponsor	Nterica Bio inc
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	5 November 2025
Primary completion	1 April 2026
Estimated completion	1 June 2026
Sites	1 location across United States

Drugs / interventions tested

• bacteriophage preparation — full drug profile →
• Bacteriophage preparation — full drug profile →
• bacteriophage preparation — full drug profile →
• bacteriophage preparation — full drug profile →

Conditions studied

• Alcohol-Associated Hepatitis — all drugs for Alcohol-Associated Hepatitis →

Sponsor

Nterica Bio inc — full company profile →

Who can join

Adults 18 to 70, any sex, with Alcohol-Associated Hepatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Frequency of adverse events
  Time frame: AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
  The number of adverse events (AEs) will be recorded.
• Changes in liver function will be evaluated
  Time frame: Assessments will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
  ALT (alanine transaminase) and AST (aspartate aminotransferase) enzymes will be evaluated

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ferroptosis and gut microbiota: A new horizon in alcohol-associated liver disease management.
   Chen Y, Gao W, Cai K, Yang L, et al · · 2025 · cited 2× · PMID 40682668 · DOI 10.1007/s00018-025-05815-5
2. Antimicrobial Resistance: The Answers.
   Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559
3. Is a Bacteriophage Approach for Musculoskeletal Infection Management an Alternative to Conventional Therapy?
   Eschweiler J, Fischer C, Migliorini F, Greven J, et al · · 2025 · PMID 41157207 · DOI 10.3390/life15101534