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The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIX 1 XX - D1 | Experimental |
| |
| BIIX 1 XX - D2 | Experimental |
| |
| BIIX 1 XX - D3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIX 1 XX - D1 | Drug |
| ||
| BIIX 1 XX - D2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to day 28 | |
| Number of subjects with abnormal changes in laboratory parameters | up to day 21 | |
| Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) | up to day 21 | |
| Number of subjects with clinically significant changes in ECG (Electrocardiogram) | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (Total Area under the plasma drug concentration time curve) | up to 336 hours after last drug administration | |
| Cmax (maximum observed concentration of the analyte in plasma) | up to 336 hours after last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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|
| BIIX 1 XX - D3 | Drug |
|
| Placebo | Drug |
|
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 336 hours after last drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 336 hours after last drug administration |
| MRT (mean time of residence of drug molecules in the body ) | up to 336 hours after last drug administration |
| CL (Total clearance of the analyte in plasma following extravascular administration) | up to 336 hours after last drug administration |