The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.
This is an ascending dose frequency study. There are two cohorts of active and placebo patients. The first cohort is dosed every 4 weeks for a total of 3 doses. The second cohort is dosed every two weeks for a total of 3 doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
24
subcutaneous injection
subcutaneous injection
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center, LLC
Dallas, Texas, United States
Pharmacokinetic parameter of ASP2408: AUCtau
Area Under the Concentration-Time curve for a dosing interval (AUCtau)
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacokinetic parameter of ASP2408: Cmax
Maximum Concentration (Cmax)
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacokinetic parameter of ASP2408: Tmax
Time to Attain Cmax (Tmax)
Time frame: Days 1, 2 ,3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacokinetic parameter of ASP2408: Ctrough
Trough Concentration (Ctrough)
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Safety assessed by adverse events (AEs), laboratory tests, electrocardiograms (ECGs), physical examinations, pulse oximetry, vital signs and Anti-ASP2408 antibody (ADA) formulation
Time frame: Up to 1 year
Composite of pharmacokinetics of ASP2408: t1/2, Vz/F, CL/F,
Apparent Terminal Elimination Half-life (t1/2), Volume of distribution (Vz/F), Apparent Body Clearance (CL/F)
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacodynamic parameter of ASP2408: CD86 receptor occupancy
Cluster of Differentiation 86, a co-stimulatory ligand on antigen-presenting cells; alternate notation for B7.2 (CD86)
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22,36, 38, 43, 50, 57, 66, 71, 72, 78, 85,113, 141
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