A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557

Exclusion Criteria

• - Acute illness at study entry;
• - Fever ≥ 99.5°F at study entry;
• - Any drug therapy within 7 days prior to Study Day 0 (except contraceptives);
• - Blood donation in excess of 400 mL within 6 months prior to study entry;
• - Receipt of immunoglobulin or blood products within 60 days prior to study entry;
• - Receipt of any investigational drug therapy or standard vaccine within 120 days prior to study drug dosing through 240 days after study drug dosing;
• - Previous receipt of palivizumab or motavizumab;
• History of immunodeficiency;
• - History of allergic disease or reactions likely to be exacerbated by any component of either study drug;
• - Previous medical history or evidence of an intercurrent illness that may compromise the safety of the subject in the study;
• - Evidence of any systemic disease on physical examination;
• - Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus-1 (HIV-1);
• - At screening (must be within 21 days before entry into the study) any of the following: hemoglobin < 12.0 gm/dL, white blood cell count (WBC) < 4,000/mm3, platelet count < 120,000/mm3 (or laboratory normal values); aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), serum creatinine > upper limit of normal (ULN); other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to be clinically significant; other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to potentially confound analysis of study results;
• - Pregnancy, or nursing mother;
• - History of alcohol or drug abuse within the past 2 years; or
• - History of asthma, seasonal allergies, or exercise-induced wheezing.