This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital
Harrow, United Kingdom
Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with TEAEs overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Number of subjects with localized administration site AEs overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with localized administration site AEs overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Maximum concentration (Cmax) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Time of maximum concentration (Tmax) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Terminal elimination half-life (T1/2) for CSL730 in serum samples
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Time frame: up to 56 days after CSL730 administration
Apparent total systemic clearance (CL/F) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Levels of anti-CSL730 antibodies detected in serum samples
Time frame: Days 15, 29, and 56