The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults. The 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 your 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
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration
Solution for single ascending IV or SC administration per the protocol
New Zealand Clinical Research
Christchurch, New Zealand
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through approximately day 162
Severity of TEAEs
Time frame: Through approximately day 162
Changes from baseline in Systolic Blood Pressure (SBP)
Time frame: Through day 6
Changes from baseline in Diastolic Blood Pressure (DBP)
Time frame: Through day 6
Changes from baseline in Mean Arterial Pressure (MAP)
Time frame: Through day 6
Changes from baseline in Pulse Pressure (PP)
Time frame: Through day 6
Concentrations of REGN7544 in serum over time
Time frame: Through approximately day 162
Incidence of treatment-emergent Anti-Drug Antibody (ADA)
Time frame: Through approximately day 162
Titer of ADA
Time frame: Through approximately day 162
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