NCT00631800

Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110

Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Biosynexus Incorporated · Industry
• Sex: All
• Age: 48 Hours – 120 Hours
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.

Detailed description

This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110 in very low birth weight neonates. A total of 80 infants will be dosed in this study. Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups.

Conditions

• Staphylococcal Sepsis

Interventions

Type	Name	Description
DRUG	Pagibaximab (formerly BSYX-A110)	Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-03-01
• Completion: 2004-11-01
• First posted: 2008-03-10
• Last updated: 2008-03-10

Locations

1 site across 1 country: United States