Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults

Exclusion Criteria

• •1. Any history of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)
• •2. Any history of allergy, anaphylaxis, or severe reaction to IGIV or human blood products
• •3. Any chronic medical problem that requires daily oral medications (except Tylenol, ibuprofen, oral contraceptives, vitamins, and seasonal allergy medications).
• •4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope
• •5. Subjects that have had confirmed MERS
• •6. Women who are breast-feeding
• •7. Positive urine or serum pregnancy test
• •8. Abnormal chemistry panel
• •-defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
• •--evaluating only sodium (Na), potassium (K), serum bicarbonate (total CO2), blood urea nitrogen (BUN), creatinine, glucose, asp (ALT), aspartate aminotransferase (AST), total bilirubin, lactate dehydrogenase (LDH), and estimated glomerular filtration rate (GFR) by the CKD-EPI equation.
• •9. Abnormal complete blood count (CBC)
• •-defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table--evaluating only the WBC (to include absolute neutrophil, lymphocyte, and eosinophil counts), hemoglobin, hematocrit, and platelets.
• •10. Abnormal urinalysis
• •-defined as any clinically significant baseline Grade 1 or greater toxicity--evaluating only protein, and RBCs
• •11. Positive rheumatoid factor
• •12. IgA deficiency (defined as IgA \< 7 mg/dL)
• •13. Participation in another research study with receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0) and until completion of the study
• •14. Participation in any other research study for 30 days after study drug administration
• •15. Receipt of blood products within 2 months prior to study drug administration (i.e. Day 0)
• •16. Receipt of any vaccination within 30 days prior to study drug administration (i.e. Day 0)
• •17. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject s ability to complete and/or participate in this clinical study