The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
single dose given via a 15 minute intravenous infusion
single dose given via a 15 minute intravenous infusion
single dose given via a 15 minute intravenous infusion
Nucleus Network
Melbourne, Victoria, Australia
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities
Time frame: From randomization through study completion (estimated up to 3 days)
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single dose given via a 15 minute intravenous infusion
single dose of normal saline given via a 15 minute intravenous infusion
single dose given via a 15 minute intravenous infusion
single dose given via a 15 minute intravenous infusion