MedTrace Logo

Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110

NCT00631878 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2008-03-10

No results posted yet for this study

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.

Conditions

  • Neonatal Staphylococcal Sepsis

Interventions

DRUG

Pagibaximab (formerly BSYX-A110)

Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 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
3 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2003-05-31
Completion
2003-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00631878 on ClinicalTrials.gov