The purpose of the study is to compare the pharmacokinetics (PK) of bimekizumab when administered subcutaneously (sc) as 1x2 mL versus 2x1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector presentation, in healthy study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
71
Study participants will receive a single-dose of bimekizumab administered subcutaneously in the Treatment Period.
Up0068 001
Berlin, Germany
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
AUC is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to infinity.
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
AUC0-t is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last observed quantifiable concentration.
Time frame: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
Cmax is the maximum observed plasma concentration.
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of 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. Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment.
Time frame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up
A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: a. Results in death, b. Is life-threatening, c. Requires inpatient hospitalization or prolongation of existing hospitalization, d. Results in persistent disability/incapacity, e. Is a congenital anomaly/ birth defect, f. Other important medical events which based on appropriate medical judgment, jeopardized the study participant and required medical or surgical intervention to prevent any of the above.
Time frame: From Baseline (Day 1) to end of Safety Follow-Up (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=-lambdaz) 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/lambdaz.
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)
tmax is the time to reach maximum plasma concentration.
Time frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140)