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

NCT00631800 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2008-03-10

No results posted yet for this study

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.

Conditions

  • Staphylococcal Sepsis

Interventions

DRUG

Pagibaximab (formerly BSYX-A110)

Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Biosynexus Incorporated

    lead INDUSTRY

Principal Investigators

  • Leonard Weisman, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
120 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2004-03-31
Completion
2004-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631800 on ClinicalTrials.gov