Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis

Exclusion Criteria

• •1. Subjects with a Class B or Class C Child-Pugh score.
• •2. Subjects with concomitant liver diseases including chronic viral hepatitis B or C, autoimmune hepatitis, PSC, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
• •3. Subjects who have previously undergone liver transplantation.
• •4. Subjects with decompensated liver disease as defined by the presence or history of any of the following:
• •* MELD score \> 15
• •* Hepatic encephalopathy
• •* Ascites
• •* Hepatorenal syndrome or serum creatinine \> 2 mg/dL
• •* Total Bilirubin \> 3.0 mg/dL
• •* INR \>1.8 unless on anticoagulation such as Coumadin
• •* History of variceal hemorrhage
• •5. Subjects with a history of cerebrovascular accident in the past 12 months.
• •6. Subjects with history of myocardial infarction, as defined by any of the following criteria:
• •* Development of pathological Q waves with or without symptoms
• •* Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause
• •* Pathological findings of a healed or healing myocardial
• •7. Subjects with chronic kidney disease, as defined by estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 for at least 3 months (per CKD EPI Equation - 2021).
• •8. Subjects with uncontrolled diabetes, as defined by HbA1c \> 7%.
• •9. Subjects who have used the following medications:
• •* Methotrexate within 90 days of screening.
• •* Immunotherapy drugs unless approved by the medical monitor.
• •10. Subjects with a history of tuberculosis or positive PPD skin test.
• •11. Subjects who have received administration of any live vaccine (other than intranasal Influenza) within 28 days or subunit vaccine within 14 days prior to screening or are planning to receive any vaccination before Day 90.
• •12. Subjects who have used systemic steroids within 3 months prior to screening.
• •13. Subjects with laboratory test results at screening or prior to study dosing that are outside the normal limits and considered by the Investigator to be clinically significant.
• •14. Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody as determined at screening.
• •15. Subjects with a history of or currently active immune disorders other that PBC (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the subject's participation in this study.
• •16. Subjects with a history of or current active diseases requiring immunosuppressive drugs (including azathioprine, prednisone, prednisolone, budesonide, cyclosporine, tacrolimus, methotrexate, or mycophenolate mofetil) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the subject's participation in this study.
• •17. Subjects with a clinical history of significant cardiovascular disease as determined by the Investigator.
• •18. Subjects with a complication or medical history of malignancy within past 5 years which, in the Investigator's opinion, makes the subject unsuitable for study participation.
• •19. Subjects who, in the Investigator's opinion, will be unable to adhere to study procedures.
• •20. Subjects who have received an investigational therapy other than CNP-104 within 28 days or 5 half-lives, whichever is longer, prior to screening.
• •21. Subjects with any condition which, in the Investigator's opinion, makes the subject unsuitable for study participation.
• •22. Known sensitivity to any components of CNP-104.