The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.
A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Single dose either subcutaneously or intravenously on day 1.
Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.
Research Site
Cypress, California, United States
Research Site
Aventura, Florida, United States
Research Site
Lenexa, Kansas, United States
Research Site
Raleigh, North Carolina, United States
Incidence of treatment emergent adverse events
Time frame: Up to day 141
Incidence of abnormal clinically significant vital signs
Time frame: Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Time frame: Up to day 141
Incidence of abnormal clinically significant ECG results
Time frame: Up to day 141
Incidence of anti-AMG 282 antibodies
Time frame: Up to 1 year
Determination of various PK parameters including tmax, AUClast and Cmax
Time frame: Up to day 141
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Research Site
Seattle, Washington, United States