This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Research Site
Anniston, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
Time frame: From 29 days to 169 days
Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
Serum concentration and derived PK parameters including Tmax, AUClast and Cmax
Time frame: From 29 days to 169 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Los Angeles, California, United States
Research Site
Michigan City, Indiana, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
Manhasset, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Duncansville, Pennsylvania, United States
...and 3 more locations