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The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIL 284 BS - rising dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIL 284 BS - rising dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 8 days after last drug administration | |
| Number of subjects with abnormal changes in laboratory parameters | up to 8 days after last drug administration | |
| Number of subjects with clinically significant changes in vital signs | Blood pressure, Pulse Rate, Respiratory Rate | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in 12-lead electrocardiogram | up to 8 days after last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours) | up to 24 hours after drug administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 80 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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|
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 80 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 80 hours after drug administration |
| MRTtot (Total mean residence time) | up to 80 hours after drug administration |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 80 hours after drug administration |
| CLtot/F (Total clearance after oral administration) | up to 80 hours after drug administration |
| Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours) | up to 24 hours after drug administration |
| AUCss (Area under the plasma concentration-time curve at steady state) | up to 80 hours after drug administration |
| Cpre,ss (Predose concentration of the analyte in plasma at steady state) | up to 80 hours after drug administration |
| Changes in Leucotriene B4 (LTB4) induced Mac-1 expression | up to 24 hours after last treatment on day 9 |