Cholangitis Clinical Trials

• Must have given written informed consent (signed and dated) and any authorizations required by local law;

• When signing ICF age ≥18 years ≤75 years, male or female;

• Meets the diagnostic criteria of PBC, based on any two of the following criteria:

‣ History of ALP above 1.0× ULN for at least 6 months

⁃ Positive antimitochondrial antibody (AMA) titer (\>1:40 on immunofluorescence or M2 positive by ELISA) or positive PBC- specific antinuclear antibody (ANA) (either SP100 or GP210 positive)

⁃ Documented liver biopsy results consistent with PBC;

• UDCA≥6 months before randomization and a stable dose ≥3 months after the efficacy was poor \[meeting inclusion criteria (5)a\], or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization);

• Central laboratory parameters measured at screening period meet the following criteria:

‣ ALP ≥1.67× ULN

⁃ ALT≤5× ULN

⁃ AST ≤5× ULN

⁃ TB \<2× ULN

⁃ Estimated glomerular filtration rate (eGFR) \> 60mL/min/1.73m2 (calculated by CKD-EPI equation)

⁃ INR ≤ 1.0× ULN. For participants on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease

⁃ Platelet count ≥ 150× 109/μL (No thrombocytopenia-related treatment within the past two weeks)

⁃ Albumin\> 35g/L

⁃ White blood cells count (WBC) \>3×109/L

‣ Absolute neutrophil count (ANC) \>1.5×109/L

‣ Hemoglobin A1c (HbA1c) ≤9.0%;

• Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.

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