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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000713-39 | EudraCT Number | EudraCT |
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The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbGn-168H very low dose i.v. | Experimental | subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo |
|
| AbGn-168H low dose i.v. | Experimental | subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo |
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| AbGn-168H medium dose i.v. | Experimental | subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo |
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| AbGn-168H high dose i.v. | Experimental | subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo |
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| AbGn-168H very low dose s.c. | Experimental | subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo |
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| AbGn-168H medium dose s.c. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbGn-168H | Drug | single very low dose of AbGn-168H i.v. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MRT sc (mean residence time of the analyte in the body after subcutaneous injection) | 6 weeks | |
| CL (total/apparent clearance of the analyte in plasma after intravascular administration) | 6 weeks | |
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Inclusion criteria:
Healthy males according to following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests
Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1304.1.4901 Boehringer Ingelheim Investigational Site | Berlin | Germany |
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| Experimental |
subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo |
|
| AbGn-168H |
| Drug |
single low dose of AbGn-168H i.v. |
|
| Placebo | Drug | single dose of Placebo i.v. |
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| Placebo | Drug | single dose of Placebo i.v. |
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| Placebo | Drug | single dose of Placebo i.v. |
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| Placebo | Drug | single dose of Placebo i.v. |
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| AbGn-168H | Drug | single medium dose of AbGn-168H i.v. |
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| AbGn-168H | Drug | single high dose of AbGn-168H i.v. |
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| AbGn-168H | Drug | single low dose of AbGn-168H s.c. |
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| Placebo | Drug | single dose of Placebo s.c. |
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| Placebo | Drug | single dose of Placebo s.c. |
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| AbGn-168H | Drug | single medium dose of AbGn-168H s.c. |
|
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) |
| 6 weeks |
| V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose) | 6 weeks |
| V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration) | 6 weeks |
| V ss (apparent volume of distribution at steady state following intravascular administration) | 6 weeks |
| C max (maximum measured concentration of the analyte in plasma) | 6 weeks |
| t max (time from dosing to maximum measured concentration) | 6 weeks |
| AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 6 weeks |
| AUC 0-tz: The area under the plasma concentration-time curve over the time interval from 0 to the last timepoint at which concentrations of AbGn-168H can be measured | 6 weeks |
| %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint | 6 weeks |
| delta z (terminal rate constant in plasma) | 6 weeks |
| t 1/2 (terminal half-life of the analyte in plasma) | 6 weeks |
| MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion) | 6 weeks |