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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022543-38 | EudraCT Number |
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To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.
To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP6038 0.3 mg/kg | Experimental |
| |
| CDP6038 1 mg/kg | Experimental |
| |
| CDP6038 3 mg/kg | Experimental |
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| CDP6038 6 mg/kg | Experimental |
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| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP6038 | Biological | 100 mg/mL solution for injection, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration (Cmax) | Multiple sampling from 0 to 113 days following single dose | |
| Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t) | Multiple sampling from 0 to 113 days following single dose | |
| Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC) | Multiple sampling from 0 to 113 days following single dose | |
| Apparent volume of distribution (Vz/F) | Multiple sampling from 0 to 113 days following single dose | |
| Apparent total body clearance (CL/F) | Multiple sampling from 0 to 113 days following single dose | |
| Terminal elimination half-life (T½) | Multiple sampling from 0 to 113 days following single dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects | Multiple sampling from 0 to 15 weeks following single dose | |
| Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guildford | Surrey | United Kingdom |
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| ID | Term |
|---|---|
| C000592400 | olokizumab |
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| Placebo | Biological | 0.9% sodium chloride for injection Single-dose |
|
| Multiple sampling from 0 to 15 weeks following single dose |