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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003478-15 | EudraCT Number |
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The Sponsor decided to terminate this study in favor of development of subcutaneous administration.
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To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL730 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL730 | Biological | Solution for IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with adverse events overall, and by causality and severity | Up to 8 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. | |
| Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | Netherlands | ||||
| Hammersmith Medicines Research |
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| Placebo | Other | Saline solution for IV infusion |
|
| Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
| Time of maximum observed concentration (Tmax) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
| Terminal elimination half-life (T1/2) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
| Total systemic clearance (CL) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
| Volume of distribution during the elimination phase (Vz) of CSL730 in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
| Number of subjects with anti-CSL730 antibodies in serum | Before study drug infusion and up to 56 days after the start of the infusion. |
| London |
| United Kingdom |