To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects. To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
20
Unnamed facility
Guildford, Surrey, United Kingdom
Maximum drug concentration (Cmax)
Time frame: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)
Time frame: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)
Time frame: Multiple sampling from 0 to 113 days following single dose
Apparent volume of distribution (Vz/F)
Time frame: Multiple sampling from 0 to 113 days following single dose
Apparent total body clearance (CL/F)
Time frame: Multiple sampling from 0 to 113 days following single dose
Terminal elimination half-life (T½)
Time frame: Multiple sampling from 0 to 113 days following single dose
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects
Time frame: Multiple sampling from 0 to 15 weeks following single dose
Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects
Time frame: Multiple sampling from 0 to 15 weeks following single dose
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