The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
100
UP0091 1
London, United Kingdom
Occurrence of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment.
Time frame: From Baseline (Day 1) to end of study Visit (up to Day 29 Part A) (up to Day 21 Part B and C)
Maximum plasma concentration (cmax) for each single dose of UCB0022 in Part A
Cmax: Maximum plasma concentration for each pre-specified single dose in Part A
Time frame: From Day 1 (predose) at predefined time points (up to Day 3)
Time to maximum plasma concentration (tmax) for each single dose of UCB0022 in Part A
tmax: time to maximum plasma concentration for each single dose of UCB0022 in Part A
Time frame: From Day 1 (predose) at predefined time points (up to Day 3)
Area under the plasma concentration-time curve from time zero to infinity (AUC) for a each dose of UCB0022 in Part A
AUC (AUCinfinity): Area under the UCB0022 plasma concentration-time curve from time zero to infinity for a each dose in Part A
Time frame: From Day 1 (predose) at predefined time points (up to Day 3)
Maximum plasma concentration during a dosing interval through steady state (Cmax, ss) for each dose UCB0022 in Part B and C
Cmax, ss: Maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C
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Time frame: From Day 1 (predose) at predefined time points (up to Day 16)
Time to maximum plasma concentration during a dosing interval through steady state (tmax, ss) for each dose UCB0022 in Part B and C
tmax, ss: time to maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C
Time frame: From Day 1 (predose) at predefined time points (up to Day 16)
Area under the plasma concentration-time curve at steady state (AUCtau) on Day 1 for a each dose of UCB0022 in Part B and C
AUCtau: Area under the plasma concentration-time curve at steady state on Day 1 for a each dose of UCB0022 in Part B and C
Time frame: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)
Area under the plasma concentration-time curve at steady state (AUCtau) on Day 14 for a each dose of UCB0022 in Part B and C
AUCtau: Area under the plasma concentration-time curve at steady state on Day 14 for a each dose of UCB0022 in Part B and C
Time frame: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)