This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6
Incidence and severity of adverse events (including bleeding events)
Time frame: Up to 136 Days
Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)
Time frame: Up to 136 Days
Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 136 Days
Pharmacokinetics of Dupilumab: Elimination half life (t1/2)
Time frame: Up to 136 Days
PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity
Time frame: Up to 136 Days
PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)
Time frame: Up to 136 Days
Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004
Time frame: Up to 136 Days
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