The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo. Subjects will be confined in the clinic for 8 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
65
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 1-8, 15, 22, 29, 43, 60, 90
Pharmacokinetic parameter of ASP2408: AUCinf
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Time frame: Days 1 -8, 15, 22, 29, 43, 60, 90
Pharmacokinetic parameter of ASP2408:Cmax
Maximum concentration (Cmax)
Time frame: Days 1-8, 15, 22, 29, 43, 60, 90
Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation
Time frame: up to 90 days
Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot
Time to attain Cmax (tmax), apparent terminal elimination half-life (t1/2), Terminal phase volume (Vz), Total Body Clearance (CLtot)
Time frame: Days 1-8, 15, 22, 29, 43, 60, 90
Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Total lymphocyte count
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Peripheral lymphocyte subset quantification
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
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