drugset / Trial / NCT02249117
Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
RandomizedParallel-groupDouble-blindTreatment
Summary
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
Timeline
- Start
- 2003-06
- Primary completion
- 2003-08
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIWH 3 | Protein / enzyme biologic | 0.02 ug/kg | Intravenous |
| Subject | BIWH 3 | Protein / enzyme biologic | 0.06 ug/kg | Intravenous |
| Subject | BIWH 3 | Protein / enzyme biologic | 0.2 ug/kg | Intravenous |
| Subject | BIWH 3 | Protein / enzyme biologic | 0.6 ug/kg | Intravenous |
| Subject | BIWH 3 | Protein / enzyme biologic | 2 ug/kg | Intravenous |
Indications
No indication recorded.