This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
32
Up0028 001
London, United Kingdom
Incidence of treatment emergent adverse events during the study
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Time frame: Day 1 up to Day 57
Maximum plasma concentration (Cmax)
Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]
Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Time to reach Cmax (Tmax)
Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7
Time frame: Predose (Day 1), Day 7
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10
Time frame: Predose (Day 1), Day 10
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13
Time frame: Predose (Day 1), Day 13
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