The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart. The secondary objectives of the study are: * To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered intravenous (IV) or subcutaneous (SC) per protocol
Administered SC per protocol
Regeneron Research Site
London, United Kingdom
Concentrations of pozelimab in serum over time
Time frame: Up to 20 weeks
Concentrations of cemdisiran in plasma over time.
Time frame: Up to 20 weeks
The incidence and severity of treatment-emergent adverse events (TEAE) in subjects administered pozelimab with/without cemdisiran
Time frame: Up to 20 weeks
Concentrations of total C5 in plasma over time
Time frame: Up to 20 weeks
Change from baseline in CH50 over time
Time frame: Up to 20 weeks
Incidence of treatment-emergent anti-drug antibodies (ADA) to pozelimab
Time frame: Up to 20 weeks
Incidence of treatment-emergent ADA to cemdisiran
Time frame: Up to 20 weeks
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