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

This study will evaluate the safety of three doses of BSYX-A110 in adults before initiating studies in the target population of low birth weight infants. This will be an open label, dose-ranging study of BSYX-A110 in 12 adults. The dose levels to be evaluated are 3, 10 and 20 mg/kg. Each dose level will enroll 4 adult volunteers who will receive one dose of BSYX-A110 intravenously. The primary endpoint of this study is safety and tolerability. The secondary endpoints include the pharmacokinetics of the rise in anti-LTA antibody and opsonic activity against S. epidermidis.

Inclusion criteria

• 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.

Exclusion criteria

• 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.