The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Miami Gardens, Florida, United States
Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects
Time frame: Entire duration of study
pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects
Time frame: Entire duration of study
pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects
Time frame: Entire duration of study
single dose immunogenicity
Time frame: Entire duration of study
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