A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

Inclusion Criteria:

- Verified diagnosis of PSC for at least 12 months, with or without IBD.

- Serum (ALP) ≥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.

- In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be
stable for at least 3 months and at a dose not greater than 20 mg/kg/day.

- Subjects of childbearing potential must agree to use a medically acceptable method of
contraceptive to prevent pregnancy in the subject and/or the partner for the duration
of their participation in the trial up to 2 months after the last study drug dosing.

Exclusion Criteria:

- Presence of documented secondary sclerosing cholangitis or small duct PSC

- Bacterial cholangitis within 30 days prior to Screening

- Presence of percutaneous drain or endoscopic bile duct stent

- History of, or suspicion of cholangiocarcinoma.

- Prior liver transplantation, or currently listed for liver transplantation

- Presence of other concomitant liver diseases

- Moderate to Severe active IBD or flare in colitis activity within the last 3 months

- Any severe and/or untreated concomitant cardiovascular, renal, endocrine or
psychiatric disorder

- Any active malignant disease (within 3 years), other than non-melanomatous skin cancer

- Human immunodeficiency virus (HIV) infection

- Existing or intended pregnancy, or breast feeding

- Has received medication from another clinical trial within the past 30 days