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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000911-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
| Richmond Pharmacology Limited | INDUSTRY |
| ACM Global Laboratories | OTHER |
| Eurofins |
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To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epratuzumab dose 1 sc | Experimental | This group of Caucasian and Japanese subjects will receive one single dose 1 of epratuzumab subcutaneous |
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| Epratuzumab dose 2 sc | Experimental | This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab subcutaneous |
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| Epratuzumab dose 3 sc | Experimental | This group of Caucasian subjects will receive one single dose 3 of epratuzumab subcutaneous |
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| Epratuzumab dose 2 iv | Active Comparator | This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab as an intra venous infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epratuzumab sc | Biological | Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous, |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t)) | From Baseline (Day 1 pre-dose) to Day 85 (End of study) | |
| Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf)) | From Baseline (Day 1 pre-dose) to Day 85 (End of study) | |
| Maximum observed plasma concentration (Cmax) | From Baseline (Day 1 pre-dose) to Day 85 (End of study) | |
| Absolute bioavailability of the tested single sc doses | From Baseline (Day 1 pre-dose) to Day 85 (End of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Time of observed Cmax (tmax) | From Baseline (Day 1 pre-dose) to Day 85 (End of study) | |
| Apparent terminal half-life (t½) | From Baseline (Day 1 pre-dose) to Day 85 (End of study) |
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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 |
|---|---|---|---|---|---|---|
| 01 | London | United Kingdom |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| INDUSTRY |
| The Doctors Laboratory Ltd | INDUSTRY |
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| Epratuzumab iv | Biological | Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous, |
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