The purpose of the study is to evaluate whether administration of bimekizumab has an effect on the expected production of antibody titers to the influenza vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
56
Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.
Up0034 001
San Antonio, Texas, United States
Seroconversion response
A subject is considered as a seroconversion responder if the following is true: subject has either a pre-vaccination HI titer ≤1/10 and a 4-week post-vaccination HI titer ≥1/40 or a pre-vaccination HI titer \>1/10 and a ≥4fold increase in HI titer 4 weeks after vaccination in at least 2 out of 4 serotypes.
Time frame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)
Plasma concentration of bimekizumab (BKZ)
Bimekizumab plasma concentrations by scheduled sampling time.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Incidence of Adverse Events (AE) from Baseline to Safety Follow Up
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.
Time frame: From Baseline to Safety Follow Up (up to Day 140)
Influenza antibody geometric mean titers (GMT)
Post-vaccination influenza antibody geometric mean titers.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Area under the BKZ plasma concentration-time curve over the first 14 days AUC(0-14)
The AUC(0-14) is the area under the plasma concentration-time curve from time zero to day 14.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 14)
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Area under the BKZ plasma concentration-time curve over the first 28 days AUC(0-28)
The AUC(0-28) is the area under the plasma concentration-time curve from time zero to day 28.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 28)
Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
The AUCt is the area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) of BKZ as determined using the linear trapezoidal rule.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
The area under the plasma concentration-time curve from time zero to infinity (AUC) of BKZ is calculated as AUC=AUCt+Clast/λz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Maximum observed BKZ plasma drug concentration (Cmax)
Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)
Tmax is the time to reach maximum plasma concentration.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Apparent terminal half-life (t1/2)
Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-λz) of natural log (ln) concentration versus time for data points in the terminal phase of the concentration-time curve. t1/2 is calculated as ln2/λz.
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)