Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody

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