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Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

NCT00636285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2008-10-09

No results posted yet for this study

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.

Conditions

  • Staphylococcal Sepsis

Interventions

DRUG

Placebo

Placebo

DRUG

BSYX-A110

BSYX-A110, Dosed intravenously, 3 mg/kg

DRUG

BSYX-A110

BSYX-A110, Dosed intravenously, 10 mg/kg

Sponsors & Collaborators

  • Biosynexus Incorporated

    lead INDUSTRY

Principal Investigators

  • Leonard Weisman, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2001-09-30
Completion
2001-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00636285 on ClinicalTrials.gov