This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Wilmington, Delaware, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Hackensack, New Jersey, United States
Frequency of treatment emergent adverse events (TEAEs)
Time frame: Baseline to Week 123
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Unnamed facility
Long Island City, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Seattle, Washington, United States