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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004987-30 | EudraCT Number | EudraCT |
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To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1005273 i.v. | Experimental | single dose i.v. infusion |
|
| BI 1005273 i.v. Placebo | Placebo Comparator | single dose i.v. infusion (Placebo) |
|
| BI 1005273 s.c. | Experimental | single dose s.c. injection |
|
| BI 1005273 s.c. Placebo | Placebo Comparator | single dose s.c. injection (Placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1005273 s.c. | Drug | injection |
| |
| BI 105273 i.v. Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| number (% subjects) with drug-related AEs. | day -21 to day 95 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | day 1 to day 90 | |
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | day 1 to day 90 |
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Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
1. Any deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1294.1.1 Boehringer Ingelheim Investigational Site | Berlin | Germany |
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| Drug |
infusion |
|
| BI 1005273 s.c. Placebo | Drug | injection |
|
| BI 1005273 i.v. | Drug | infusion |
|
| AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose) | day 1 to day 90 |