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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002251-34 | EudraCT Number | EudraCT |
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To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 655064 subcutaneous | Experimental | Escalating single dose as solution for subcutaneous injection |
|
| Placebo to BI 655064 subcutaneous | Placebo Comparator | Escalation single dose as solution for subcutaneous injection (Placebo) |
|
| BI 655064 intravenous | Experimental | Escalating single dose as solution for intravenous infusion |
|
| Placebo to BI 655064 intravenous | Placebo Comparator | Escalating single dose as solution for intravenous infusion (Placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 655064 | Drug | intravenous infusion of escalating doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vital signs (blood pressure [BP], pulse rate [PR]) | up to 70 days post treatment | |
| Changes in 12-lead ECG (electrocardiogram) | up to 70 days post treatment | |
| Incidence of adverse events | up to 70 days post treatment | |
| Assessment of global tolerability by investigator | up to 70 days post treatment | |
| Assessment of local tolerability by investigator | up to 70 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma | up to 1656 hours post treatment | |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | up to 1656 hours post treatment |
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Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1293.1.1 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29127458 | Derived | Albach FN, Wagner F, Huser A, Igel J, Joseph D, Hilbert J, Schoelch C, Padula SJ, Steffgen J. Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases. Eur J Clin Pharmacol. 2018 Feb;74(2):161-169. doi: 10.1007/s00228-017-2362-8. Epub 2017 Nov 10. |
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| ID | Term |
|---|---|
| C000627991 | BI 655064 |
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| Placebo to BI 655064 |
| Drug |
subcutaneous injection of escalating doses |
|
| BI 655064 | Drug | intravenous infusion of escalating doses |
|
| BI 655064 | Drug | subcutaneous injection of escalating doses |
|
| 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 | up to 1656 hours post treatment |