This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
IBI355 IV. Q4W
IBI355 placebo IV. Q4W
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Incidence of adverse events and serious adverse events
Time frame: up to week 24
Area under the Curve(AUC) of multi-dose of IBI355
Time frame: Up to week 16
Peak serum concentration(Cmax) of multi-dose of IBI355
Time frame: Up to week 16
Clearance (CL) of multi-dose of IBI355
Time frame: Up to week 16
Half-life (t1/2) of multi-dose of IBI355
Time frame: Up to week 16
The ratio of Anti-drug antibody of multi-dose of IBI355
Time frame: Up to week 24
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