This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants. This study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Administered sequential, ascending single intravenous (IV) dose
Administered sequential, ascending single subcutaneous (SC) dose
Administered sequential, ascending single intravenous (IV) dose
Administered sequential, ascending single subcutaneous (SC) dose
Labcorp Clinical Research Unit
Leeds, United Kingdom
Incidences of treatment-emergent adverse events (TEAE)
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Time frame: Up to 36 days
Severity of TEAE
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Time frame: Up to 36 days
Change from baseline in activated partial thromboplastin time (aPTT)
Time frame: Up to 36 days
Change from baseline in prothrombin time (PT)
Time frame: Up to 36 days
Concentrations of total REGN7508 in serum
Time frame: Up to 36 days
Concentrations of functional REGN7508 in plasma
Time frame: Up to 36 days
Absolute concentration and change from baseline in total Factor XI (FXI) concentrations
Time frame: Up to 36 days
Absolute concentration and change from baseline in free FXI concentrations
Time frame: Up to 36 days
Incidence of antidrug antibodies (ADAs) to REGN7508 over time
Time frame: Up to 36 days
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