The primary objective of this study is to characterize the PK properties of a single dose of gefurulimab in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Participants will receive gefurulimab subcutaneously (SC).
Research Site
Shanghai, China
Maximum Observed Serum Concentration (Cmax) of Gefurulimab
Time frame: Day 1 predose through Day 92 postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Gefurulimab
Time frame: Day 1 predose through Day 92 postdose
Serum Free Complement Component 5 (C5) Concentration
Time frame: Day 1 predose through Day 92 postdose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through Day 92
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Day 1 through Day 92
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated With Prefilled Syringe With Needle Safety Device (PFS-SD)
Time frame: Day 1 through Day 92
Number of Participants With Successful and Failed Dose Administrations
Time frame: Day 1 through Day 92
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