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

This is an interventional treatment trial for Middle East Respiratory Syndrome Coronavirus focused on measuring First in Human, Middle East Respiratory Syndrome (MERS), Tc Bovine-Derived, Transchromosomic Cattle Read More

• INCLUSION CRITERIA:

  1. Age greater than or equal to 18 years and less than or equal to 60 years
  2. Body mass index (BMI) of 19-32 kg/m(2)
  3. Estimated glomerular filtration rate greater than or equal to 70 mL/min at screening, calculated using the CKD-EPI formula
  4. Subjects must agree to:

• Not take any prescription or OTC medications with the exception of acetaminophen, ibuprofen, vitamins, seasonal allergy medications, and/or contraceptive medications for a period 7 days prior to study drug administration (i.e., Day 0)

  5. One of the following in order to avoid pregnancy:

• Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of the subject s signing of the informed consent form through 60 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method.
• Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject s signing of the informed consent form through 60 days after the last dose of study drug.

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