This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults. The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers. 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 present in the blood of study participants 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
56
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Administered IV or SC, sequential ascending single dose
New Zealand Clinical Research
Christchurch, Canterbury, New Zealand
Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
Time frame: Baseline to day 113
Severity of TEAE's through the EOS visit
Time frame: Baseline to day 113
Concentrations of functional REGN13335 in plasma through the EOS visit
Time frame: Baseline to day 113
Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time
Time frame: Baseline to day 113
Titer of ADA to single doses of REGN13335 over time
Time frame: Baseline to day 113
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