Healthy Male Volunteers
Conditions
Keywords
Phase 1, UCB0107
Brief summary
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.
Interventions
DRUGUCB0107
* Pharmaceutical form: solution for infusion * Route of administration: intravenous use
OTHERPlacebo
* Pharmaceutical form: intravenous infusion * Route of administration: intravenous use
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is male, \>= 18 and \<= 75 years of age * Subject has a body mass index (BMI) \>= 18.0 and \< 30.0 kg/m\^2, with a body weight of at least 50 kg and maximum 100 kg * Subject is in good physical and mental health * Subject has clinical laboratory test results within the reference ranges of the laboratory * Subject's electrocardiogram (ECG) is considered normal, or abnormal but clinically non-significant (as interpreted by the investigator) * Male subject confirms that, during the study period and for a period of 6 months or 5 half-lives of the investigational medicinal product (IMP) (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier AND an additional highly effective contraceptive method by the female partner
Exclusion criteria
* Subject is an employee or direct relative of an employee of the contract research organization (CRO) or UCB * Subject has previously been assigned to treatment in this study or in another study of the medication under investigation in this study * Subject is considered to be a vulnerable participant * Subject has had major surgery (including joint surgery) within 6 months prior to Screening, or has planned surgery within 6 months after study treatment * Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 4 weeks before the first dose of IMP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of Adverse Events (AEs) during the study | During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | AUC: area under the concentration-time curve from time 0 to infinity |
| 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 | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration |
| The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | tmax: time to maximum observed serum concentration |
| The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | Cmax: maximum observed serum concentration |
| The total Clearance (CL) for UCB0107 in serum | Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) | CL: clearance |
| The volume of distribution (Vz) for UCB0107 in serum | Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) | Vz: volume of distribution. |
| CSF/serum ratio of antibody concentrations | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | Ratio of the antibody concentrations in cerebrospinal fluid and serum |
| The terminal half-life (t½) of UCB0107 in serum | Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) | t1/2: terminal half-life |
Countries
Germany
Outcome results
None listed