drugset / Trial / NCT00631878
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
RandomizedParallel-groupDouble-blindPrevention
Summary
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
Timeline
- Start
- 2001-11
- Primary completion
- 2003-05
- Completion
- 2003-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pagibaximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pagibaximab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Subject | Pagibaximab | Monoclonal antibody | 60 mg/kg | Intravenous |
| Subject | Pagibaximab | Monoclonal antibody | 90 mg/kg | Intravenous |