The purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
52
Up0047 001
Berlin, Germany
The incidence of Adverse Events (AEs) during the study
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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)
The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid
Cmax: maximum observed serum concentration
Time frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid
AUC: area under the concentration-time curve from time 0 to infinity
Time frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration (AUC(0-t)) in serum and cerebrospinal fluid
AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
Time frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid
tmax: time to maximum observed serum concentration
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Time frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The terminal half-life (t½) of UCB0107 in serum
t1/2: terminal half-life
Time frame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
The total Clearance (CL) for UCB0107 in serum
CL: clearance
Time frame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
The volume of distribution (Vz) for UCB0107 in serum
Vz: volume of distribution.
Time frame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
CSF/serum ratio of antibody concentrations
Ratio of the antibody concentrations in cerebrospinal fluid and serum
Time frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)