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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000475-32 | EudraCT Number |
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The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB0107 | Experimental | Subjects will be randomized to receive a predefined dosage of UCB0107 in order to maintain the blinding. |
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| Placebo | Placebo Comparator | Subjects will be randomized and receive a placebo in order to maintain the blinding. |
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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 treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. | From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days |
| Maximum observed serum concentration of UCB0107 during the study | Pharmacokinetic variable: Cmax: maximum observed serum concentration | The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 |
| Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study | Pharmacokinetic variable: AUC: area under the concentration-time curve from time 0 to infinity | The blood samples for serum Pharmacokinetics will be taken from predose to Day 140 |
| Area under the concentration-time curve from time 0 to time t of UCB0107 during the study | Pharmacokinetic variable: AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration | The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 |
| Terminal half-life of UCB0107 during the study | Pharmacokinetic variable: t1/2: terminal half-life | The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 |
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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 |
|---|---|---|---|---|---|---|
| Up0065 001 | London | United Kingdom |
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| Placebo | Other |
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| Volume of distribution of UCB0107 during the study | Pharmacokinetic variable: Vz: volume of distribution | The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 |
| The clearance of UCB0107 during the study | Pharmacokinetic variable: CL: clearance | The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 |
| The time to maximum observed serum concentration of UCB0107 during the study | Pharmacokinetic variable: tmax: time to maximum observed serum concentration | The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 |