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Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte, coagulation, platelet and endothelial activation will be quantified; To examine the safety of BIWH 3 in this setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIWH 3 | Experimental | single escalating dose |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIWH 3 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) | up to 14 days after drug administration | |
| Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz) | up to 14 days after drug administration | |
| maximum BIWH 3 plasma concentration (Cmax) | up to 14 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Monocyte activation | Quantification of leukocyte surface markers by flow cytometry | up to 14 days after drug administration |
| Platelet cell activation | Quantification of soluble P-selectin by enzyme immunoassay |
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Inclusion Criteria:
Exclusion Criteria:
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|
| up to 14 days after drug administration |
| Endothelial cell activation | Quantification of soluble E-selectin by enzyme immunoassay | up to 14 days after drug administration |
| Inflammatory response | Quantification of mRNA expression of IL-1 by reverse transcriptase-polymerase chain reaction (RT-PCR) | up to 14 days after drug administration |
| Activation of coagulation | Prothrombin fragment levels via an enzyme-immunoassay | up to 14 days after drug administration |
| Number of subjects with adverse events | up to 14 days after drug administration |
| Number of subjects with clinically significant findings in vital signs | blood pressure, pulse rate, body temperature | up to 14 days after drug administration |
| Number of subjects with clinically significant findings in ECG | up to 14 days after drug administration |
| Number of subjects with clinically significant findings in laboratory tests | up to 14 days after drug administration |