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To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A, CDP6038 0.001 mg/kg, iv | Experimental |
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| Cohort B, CDP6038 0.01 mg/kg, iv | Experimental |
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| Cohort C, CDP6038 0.03 mg/kg, iv | Experimental |
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| Cohort D, CDP6038 0.1 mg/kg, iv | Experimental |
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| Cohort E, CDP6038 0.3 mg/kg, iv | Experimental |
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| Cohort G, CDP6038 1.0 mg/kg, iv | Experimental |
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| Cohort I, CDP6038 3.0 mg/kg, iv | Experimental |
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| Cohort K, CDP6038 10.0 mg/kg, iv |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP6038 | Biological | 100 mg/mL solution for injection Single infusion over 60 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects. | Baseline to 14 weeks | |
| The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | |
| The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | |
| The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | |
| The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | |
| Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | |
| PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. | Baseline to 14 weeks |
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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 |
|---|---|---|---|---|---|---|
| Berlin | Germany |
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| ID | Term |
|---|---|
| C000592400 | olokizumab |
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| Experimental |
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| Cohort A, Placebo, iv | Placebo Comparator |
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| Cohort B, C, D, E, G, I, K, Placebo, iv | Placebo Comparator |
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| Cohort F, CDP6038 0.3 mg/kg, sc | Experimental |
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| Cohort H, CDP6038 1.0 mg/kg, sc | Experimental |
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| Cohort J, CDP6038 3.0 mg/kg, sc | Experimental |
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| Cohort F, H, J, Placebo, sc | Placebo Comparator |
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| CDP6038 | Biological | 100 mg/mL solution for injection Single infusion over 120 minutes |
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| CDP6038 | Biological | 100 mg/mL solution for injection Single sc injection |
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| Placebo | Other | 0.9% sodium chloride for injection Single infusion over 60 minutes |
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| Placebo | Other | 0.9% sodium chloride for injection Single infusion over 120 minutes |
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| Placebo | Other | 0.9% sodium chloride for injection Single sc injection |
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