Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110

Exclusion Criteria

• •Patients may have none of the following at either the first or second dose:
• •1. Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
• •2. Life threatening hemodynamic instability
• •3. Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) as determined by history and/or physical examination and including but not limited to:
• •i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
• •4. Known or suspected hepatic or renal insufficiency
• •5. Persistent seizure disorder
• •6. Immunodeficiency other than due to prematurity
• •7. A history of immune globulin administration prior to first study drug infusion
• •8. Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
• •9. Any of the following laboratory findings
• •1. BUN or creatinine \> 1.5 x upper limit of normal for age
• •2. AST (SGOT), ALT (SGPT) or total bilirubin \> 1.5 x upper limit of normal age
• •3. Direct bilirubin of \> 2.0 mg/dL
• •4. Hemoglobin \< 9.0gm/dL
• •5. White Blood Count \< 2,000 cells/mm3
• •10. Currently receiving or recently received other investigational agents that could interfere with conduct or results of this study. Each patient receiving other investigational agents will be reviewed by the investigator or his designee with the Sponsor prior to the patient's entry into the study.
• •11. Expectation that the patient will not be able to be followed for the duration of the study.
• •12. Mother with serology positive for hepatitis B surface antigen
• •13. Receipt of Hepatitis B vaccine since birth