A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Study Site
Berlin, Germany
Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
Time frame: From the start of infusion to 24 hours after the end of infusion
Incidence of adverse events (AEs) within 10 days of the CSL830 infusion
Time frame: From the start of infusion to 10 days after the infusion
Relative bioavailability of CSL830 versus Berinert - Cmax
Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert
Time frame: 240 hours
Relative bioavailability of CSL830 versus Berinert - AUC
Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert
Time frame: 240 hours
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