The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
105
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Orange, California, United States
Unnamed facility
DeLand, Florida, United States
PD parameters
Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)
Time frame: baseline through week 4
Percentage of TEAEs
Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).
Time frame: baseline through week 6
PK parameters
Pharmacokinetic (PK) parameters, what the body does to a drug, will be collected from baseline through week 4: * AUC * CL (clearance) * Cmax (the peak concentration) * t1/2 (observed terminal half-life)
Time frame: baseline through week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Edgewater, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Miami Lakes, Florida, United States
Unnamed facility
Granger, Indiana, United States
Unnamed facility
Grand Blanc, Michigan, United States
Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Cinicinnati, Ohio, United States
...and 9 more locations