The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.

Inclusion Criteria:

• Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC)
• Elevated liver enzyme levels at screening
• Have given written informed consent

Exclusion Criteria:

• Screening bilirubin > 2.9 mg/dL (50 μmol/L)
• Screening creatinine clearance < 80 ml/min
• History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites)
• Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
• Known or previous diagnosis of malignancy
• Presence of any active infection
• Previous history of active TB within 12 months of screening