The primary objective of the study is to evaluate the safety and tolerability of ascending doses of 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 assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart * To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart * To assess the immunogenicity of pozelimab and cemdisiran
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Single dose administered subcutaneously
Single dose administered SC
Regeneron Research Site
Antwerp, Belgium
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 20 weeks
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
Concentrations of total C5 over time
Time frame: Up to 20 weeks
Change from baseline in total complement hemolytic activity assay (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 anti-drug antibodies (ADA) to cemdisiran
Time frame: Up to 20 weeks
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