Clinical Phase 1 study to investigate the pharmacokinetics and to assess the safety and tolerability of recAP after single and multiple intravenous doses in healthy Japanese subjects.
This study is a randomized, double blind, parallel group, single-center trial, consisting of a single dose part and a multiple dose part in 32 healthy Japanese subjects. Since all these doses have been studied before and safety extensively evaluated in non-Japanese subjects and no ethnic sensitivity is expected, the groups can be dosed in parallel. Part A will have 3 parallel groups of 8 male subjects with N=6 on active and N=2 on placebo per group. Following baseline assessments, a single dose of recAP will be administered by a one-hour infusion followed by samplings for pharmacokinetic evaluation and routine safety assessments. Part B will have a single group of 8 male subjects with N=6 on active and N=2 on placebo. Following baseline assessments, recAP will be dosed on Days 1, 2 and 3 by one-hour infusions followed by samplings for pharmacokinetic evaluation and routine safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Intravenous infusion
Intravenous infusion
Intravenous infusion
P-One Clinic, Keikokai Medical Corporation
Tokyo, Japan
Maximum observed recAP plasma concentration (Cmax) after single dose
Blood collection for cmax evaluation daily from Day 1 to Day 9
Time frame: Single dose 9 days treatment phase
Time to attain maximum recAP serum concentration (Tmax) after single dose
Blood collection for Tmax evaluation daily from Day 1 to Day 9
Time frame: Single dose 9 days treatment phase
Area under the plasma concentration versus time curve (AUC) after single dose
Blood collection for AUC evaluation daily from Day 1 to Day 9
Time frame: Single dose 9 days treatment phase
recAP elimination half-life ( t1/2) after single dose
Blood collection for t1/2 evaluation daily from Day 1 to Day 9
Time frame: Single dose 9 days treatment phase
Maximum observed recAP plasma concentration (Cmax) after multiple doses
Blood collection for cmax evaluation daily from Day 1 to Day 13
Time frame: Multiple doses 13 days treatment phase
Time to attain maximum recAP serum concentration (Tmax) after multiple doses
Blood collection for Tmax evaluation daily from Day 1 to Day 13
Time frame: Multiple doses 13 days treatment phase
Area under the plasma concentration versus time curve (AUC) after multiple doses
Blood collection for AUC evaluation daily from Day 1 to Day 13
Time frame: Multiple doses 13 days treatment phase
recAP elimination half-life ( t1/2) after multiple doses
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Intravenous infusion
Intravenous infusion
Blood collection for t1/2 evaluation daily from Day 1 to Day 13
Time frame: Multiple doses 13 days treatment phase
Adverse events (AEs) after single dose
Any untoward medical occurrence in a subject enrolled into a clinical study regardless of its causal relationship to study drug.
Time frame: Single dose 9 days treatment phase
Adverse events (AEs) after multiple doses
Any untoward medical occurrence in a subject enrolled into a clinical study regardless of its causal relationship to study drug.
Time frame: Multiple doses 13 days treatment phase