drugset / Trial / NCT00636285
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers. Following the demonstration of safety in adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized low birth weight neonates.
Timeline
- Start
- 2001-04
- Primary completion
- 2001-09
- Completion
- 2001-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pagibaximab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Pagibaximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pagibaximab | Monoclonal antibody | 20 mg/kg | Intravenous |