This study is designed to evaluate the safety and tolerability of UCB7858 when given as single ascending doses administered by intravenous or subcutaneous infusion in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
78
Up0029 001
London, United Kingdom
Incidence of adverse events following administration of UCB7858
Time frame: Cohort 1-10: Day 1 up to Day 72 Cohort 11: Day 1 up to Day 120
Maximum plasma concentration (Cmax)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Time to reach Cmax (tmax)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Area under the curve from 0 to infinity (AUC)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
The terminal plasma half-life (t1/2) following intravenous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Plasma clearance (CL) of UCB7858 following intravenous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Volume of distribution (Vss) for UCB7858 at steady state following intravenous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Apparent volume of distribution (Vss/F) of UCB7858 following subcutaneous administration
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Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Apparent plasma clearance (CL/F) of UCB7858 following subcutaneous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Mean absolute bioavailability (F) of UCB7858 given subcutaneously, using the ratio of geometric mean AUCs for subcutaneous (sc) administration and intravenous (iv) infusion (AUC_sc/AUC_iv)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Concentration of UCB7858 at the end of infusion (Cinf)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Time at the end of infusion of UCB7858 (tinf)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120