To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
67
Unnamed facility
Berlin, Germany
The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.
Time frame: Baseline to 14 weeks
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0.9% sodium chloride for injection Single infusion over 60 minutes
0.9% sodium chloride for injection Single infusion over 120 minutes
0.9% sodium chloride for injection Single sc injection