The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.
This clinical study will be conducted as a double-blind, placebo-controlled, single ascending subcutaneous dose study. As shown in the table below, the study will be conducted using 3 cohorts, to which a total of 24 subjects will be randomly assigned (18 subjects receiving ASP2408 and 6 subjects receiving placebo). Each cohort will consist of 8 subjects, who will be randomly assigned to either the ASP2408 group or the placebo group at the ratio of 3 to 1. Each subject will need to be hospitalized until Day 8 (start date of study drug administration will be regarded as Day 1) and will be observed until Day 90. The investigator or subinvestigator will carefully observe each subject for any sign or symptom of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Unnamed facility
Kyushu, Japan
Safety assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECG
Time frame: Up to 90 days after administration
Pharmacokinetics of serum ASP2408
The pharmacokinetic analysis employed non-compartmental methods using serum concentrations of ASP2408. The following pharmacokinetic parameters were estimated: AUCinf, AUClast, Cmax, CL/F, tmax, t1/2, and Vz/F.
Time frame: On day-1, day-2, day-3, day-4, day-5, day-6, day-7, day-8, day-9, day-11, day-13, day-15, day-22, day-29 day-43, day-60 and day-90
CD80/CD86 receptor occupancy
Time frame: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Total lymphocyte count
Time frame: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Peripheral blood lymphocyte subset
Time frame: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
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