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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013617-10 | EudraCT Number |
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To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP7657 | Experimental | CDP7657 in dose escalating cohorts |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP7657 | Biological | Ascending single doses of CDP7657 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety of CDP7657 as per Adverse Event (AE) reporting | Day 0 to 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Day 0 to 119 | |
| Time corresponding to Cmax (Tmax) | Day 0 to 119 | |
| Terminal elimination half-life (t 1/2) |
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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 |
|---|---|---|---|---|---|---|
| 6 | Leuven | Belgium | ||||
| 9 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25784719 | Derived | Tocoian A, Buchan P, Kirby H, Soranson J, Zamacona M, Walley R, Mitchell N, Esfandiari E, Wagner F, Oliver R. First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Lupus. 2015 Sep;24(10):1045-56. doi: 10.1177/0961203315574558. Epub 2015 Mar 16. |
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| Other |
Placebo: 0.9% sodium chloride aqueous solution |
|
| Day 0 to 119 |
| Plasma levels of anti-CDP7657 antibodies | Day 0 to 119 |
| Sofia |
| Bulgaria |
| 1 | Berlin | Germany |
| 2 | Erlangen | Germany |
| 3 | Frankfurt | Germany |
| 4 | Hanover | Germany |
| 8 | Kiel | Germany |
| 7 | Münster | Germany |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001327 | Autoimmune Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D017437 | Skin and Connective Tissue Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000607972 | dapirolizumab pegol |
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