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

Completed · Phase 1 · Has a placebo group

Conditions studied: Staphylococcal Sepsis

In brief

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.

Key facts

Study ID

NCT00636285

Run by

Biosynexus Incorporated

People needed

8

Starts

2001-04-01

Expected to finish

2001-11-01

Last updated by the study team

2008-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be 18 years of age or older.
• Subjects must in good general health, without significant medical history, physical examination findings or clinical laboratory abnormalities.
• Negative screening pre-treatment pregnancy test for female subjects.
• Subjects of childbearing potential must agree to use an acceptable method of contraception throughout the course of the study.
• All aspects of the protocol explained and written informed consent obtained.

You may not qualify if…

• Known or suspected immunodeficiency (e.g. HIV infection, significant risk factors for HIV, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression.
• Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
• Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
• History of leukemia, lymphoma or other malignancy.
• Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
• Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
• Receipt of any vaccine within 30 days.
• History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study.
• Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
• Participation in another investigational drug or vaccine trial within 30 days.

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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