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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003315-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB0107 | Experimental | Subjects randomized to this arm will receive UCB0107. This arm will consist of a maximum of 7 cohorts. The dose for cohort 1 will be fixed, proposed doses for cohorts 2,3,4,5,6 and 7 may be adapted based upon recommendation by the Safety Review Group. |
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| Placebo | Placebo Comparator | Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0107 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid | Cmax: maximum observed serum concentration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0047 001 | Berlin | Germany |
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| Placebo | Other |
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AUC: area under the concentration-time curve from time 0 to infinity |
| 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 | 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 | 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 | 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 | 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. | 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 | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) |