To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,
Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,
01
London, United Kingdom
Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t))
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf))
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Maximum observed plasma concentration (Cmax)
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Absolute bioavailability of the tested single sc doses
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Time of observed Cmax (tmax)
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Apparent terminal half-life (t½)
Time frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
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