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.
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.
1. Subjects must be 18 years of age or older.
2. Subjects must in good general health, without significant medical history, physical
examination findings or clinical laboratory abnormalities.
3. Negative screening pre-treatment pregnancy test for female subjects.
4. Subjects of childbearing potential must agree to use an acceptable method of
contraception throughout the course of the study.
5. All aspects of the protocol explained and written informed consent obtained.
1. 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.
2. Clinically significant laboratory abnormality (greater than 1.5 upper limit of
3. Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
4. History of leukemia, lymphoma or other malignancy.
5. Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
6. Pregnant or lactating females (women of childbearing potential will undergo a
7. Receipt of any vaccine within 30 days.
8. 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.
9. Fever or acute illness within 3 days prior to treatment. (These subjects can be
rescheduled for treatment at a later date).
10. Participation in another investigational drug or vaccine trial within 30 days.