The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material.
The four doses will be studied in sequential cohorts of 8 subjects each, starting with the IV dose, followed by the subcutaneous doses in ascending order of dose. Within each cohort, subjects will be randomized to either active drug or matching placebo in a 3:1 ratio (6 active and 2 placebo). All subjects in each arm will be confined for 8 days and followed for a minimum of 90 days up to 9 months if necessary. Subjects who have study drug terminated should remain in the study, if possible and have scheduled procedures and follow-up. Subjects who have detectable blood levels of ASP2408 after Day 90 will be unblinded and followed monthly until ASP2408 levels are below the limit of quantification. In addition, subjects who have persistent anti-ASP2408 antibodies after Day 90 will be unblinded and followed every 30 (± 3) days for up to 9 months until the level of these antibodies are declining, no longer detectable, and/or have no clinical consequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
Parexel International
Baltimore, Maryland, United States
Pharmacokinetic parameter of ASP2408: AUClast
Area under the concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacokinetic parameter of ASP2408: AUCinf
Area under the concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacokinetic parameter of ASP2408: Cmax
Maximum concentration (Cmax)
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Safety assessed by adverse events (AEs), laboratory tests, immunoglobulin quantification (class), 12-lead electrocardiograms, vital signs and anti-ASP2408 antibody formation
Time frame: Up to day 90
Composite of pharmacokinetics of ASP2408: tmax, t 1/2, Vz/F, CL/F and F (%)
Time to attain Cmax (tmax), apparent terminal elimination half-life (t 1/2), apparent volume of distribution (Vz/F), apparent body clearance (CL/F) and absolute bioavailability (F%)
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacodynamic Profile: CD80 and CD86 receptor occupancy, peripheral lymphocyte subset quantification (leukocyte phenotypes) and total lymphocyte count
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60 and 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.