The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
Up0065 001
London, United Kingdom
The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days
Maximum observed serum concentration of UCB0107 during the study
Pharmacokinetic variable: Cmax: maximum observed serum concentration
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study
Pharmacokinetic variable: AUC: area under the concentration-time curve from time 0 to infinity
Time frame: The blood samples for serum Pharmacokinetics will be taken from predose to Day 140
Area under the concentration-time curve from time 0 to time t of UCB0107 during the study
Pharmacokinetic variable: AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Terminal half-life of UCB0107 during the study
Pharmacokinetic variable: t1/2: terminal half-life
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
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Volume of distribution of UCB0107 during the study
Pharmacokinetic variable: Vz: volume of distribution
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
The clearance of UCB0107 during the study
Pharmacokinetic variable: CL: clearance
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
The time to maximum observed serum concentration of UCB0107 during the study
Pharmacokinetic variable: tmax: time to maximum observed serum concentration
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140