The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab produced by the original manufacturing process (Process A) compared to a second manufacturing process (Process B) The secondary objectives of the study are: * Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2 manufacturing processes * Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Single subcutaneous (SC) injection
Regeneron Study Site
Antwerp, Belgium
Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A
Time frame: Up to 16 weeks
Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B
Time frame: Up to 16 weeks
Assess peak concentration (Cmax) PK profile of pozelimabin in Process A
Time frame: Up to 16 weeks
Assess peak concentration (Cmax) PK profile of pozelimab in Process B
Time frame: Up to 16 weeks
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 16 weeks
Incidence of anti-drug antibodies (ADA) to pozelimab over time
Time frame: Up to 16 weeks
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