To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Grp.1: 3 mg/kg IV (single dose)
Grp. 2: 15 mg/kg IV (single dose)
Grp. 3: 30 mg/kg IV (single dose)
SFBC International, Inc
Miami, Florida, United States
Safety
Time frame: 30 days after patient's final dose of study drug
Pharmacokinetics
Time frame: Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2.
Immunogenicity
Time frame: 150 days after final dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Grp. 4: 3 mg/kg IM (single dose)
Grp.5: 3 mg/kg IM (two doses)