Healthy Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Crossover, Single Dose Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers
The study will be a double-blind, randomized, crossover, single-dose assessment of
IV-administered GC4711 compared to GC4419 in healthy volunteers.
Consenting subjects will undergo screening procedures within 28 days of the start of dosing.
Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine
from all subjects.
Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will
receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety
review by the Galera study team , if no safety concerns are identified after the last subject
completes study participation, enrollment will continue in 2 stages to a crossover study
design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are
identified in stage 1 following a clinical safety review by the Galera study team, 20
subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover
design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) ->
Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first
treatment they were randomized to, and on Day 4 (following a washout), they will receive the
second treatment. Subjects will be followed up for 2 days after the second treatment.
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