A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

Inclusion Criteria:

1. Able to provide written informed consent (either from patient or patient's legally
acceptable representative)

2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2

3. Patients with alcoholic hepatitis defined as:

1. History of heavy alcohol abuse: > 40 g/day in females or > 60 g/day in males for
a minimum period of 6 months, AND

2. Consumed alcohol within 12 weeks of entry into the study, AND

3. Serum bilirubin > 3 mg/dL AND AST > ALT, but less than 300 U/L AND

4. MELD score between 11-30, inclusive

4. No evidence of active infection as determined by the investigator.

5. Women of child-bearing potential must utilize appropriate birth control throughout the
study duration.

6. Male patients must agree to use a medically acceptable method of contraception/birth
control throughout the study duration

Exclusion Criteria:

1. Other or concomitant cause(s) of liver disease as a result of:

1. Autoimmune liver disease

2. Wilson disease

3. Vascular liver disease

4. Drug induced liver disease

2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B

3. Any active malignancies other than curatively treated skin cancer (basal cell or
squamous cell carcinomas)

4. If female, known pregnancy, or has a positive serum pregnancy test, or
lactating/breastfeeding

5. Serum creatinine > 2.5 mg/dL

6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone
marrow, or stem cell etc.), other than cornea transplant

7. Stage 3 or greater encephalopathy by West Haven criteria