Study CSL324\_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Scientia Clinical Research Ltd
Randwick, Australia
Maximum concentration (Cmax) of CSL324 in serum
Time frame: From Day 1 to Day 56
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
Time frame: From Day 1 to Day 56
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum
Time frame: From Day 1 to Day 56
Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality
Time frame: Up to Day 56
Percentage of subjects with TEAEs by incidence, by severity, and by causality
Time frame: Up to Day 56
Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Time frame: Up to Day 7
Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Time frame: Up to Day 7
Time to reach Cmax (Tmax) for CSL324 in serum
Time frame: From Day 1 to Day 56
Terminal half-life (t1/2) for CSL324 in serum
Time frame: From Day 1 to Day 56
Apparent clearance (CL/F) for CSL324 in serum
Time frame: From Day 1 to Day 56
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Apparent volume of distribution (Vz/F) for CSL324 in serum
Time frame: From Day 1 to Day 56
Number of subjects with or without anti-CSL324 antibodies
Time frame: Up to Day 56
Percentage of subjects with or without anti-CSL324 antibodies
Time frame: Up to Day 56