To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
26
PRA Health Sciences
Groningen, Netherlands
Hammersmith Medicines Research
London, United Kingdom
Percentage of subjects with adverse events overall, and by causality and severity
Time frame: Up to 8 weeks after infusion
Maximum observed concentration (Cmax) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Time of maximum observed concentration (Tmax) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Terminal elimination half-life (T1/2) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Total systemic clearance (CL) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Volume of distribution during the elimination phase (Vz) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Number of subjects with anti-CSL730 antibodies in serum
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Time frame: Before study drug infusion and up to 56 days after the start of the infusion.