Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
Condition: Middle East Respiratory Syndrome Coronavirus
MeSH terms: Coronavirus Infections
Intervention: SAB-301; Normal (9%) Saline
Intervention description: SAB-301 is a purified human immune globulin G (hIgG) polyclonal antibody designed to specifically bind to the MERS-CoV spike (S) protein, a component of the virion membrane that is responsible for binding of the virus to the host cell. The hIgG is purified from the plasma of immunized transchromosomic (Tc) bovines that were immunized with a recombinant spike protein produced in insect cells. SAB-301 is purified hIgG in a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.; Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: First in Human; Middle East Respiratory Syndrome (MERS); Tc Bovine-Derived; Transchromosomic Cattle

Summary:

      Background:

      Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal
      respiratory virus. People often get MERS through close contact with an infected person.
      Scientists are worried that MERS may spread and cause more infections. There are no vaccines
      or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able
      to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of
      antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid
      part of cow blood.

      Objective:

      To evaluate the safety and tolerability of SAB-301 in healthy adults.

      Eligibility:

      Healthy people ages 18 60 who:

      Do not have chronic medical problems

      Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal
      allergy meds and oral contraception)

      Do not have allergies to beef products

      Agree to use two forms of contraception while on study (both men and women)

      Design:

      Participants will be screened with:

      Medical history

      Physical examination

      Blood and urine tests

      Participants will have a return visit.

      They will have a physical exam and blood tests.

      They will be randomly assigned to receive either SAB-301 or a placebo which is given by
      infusion

      through an arm vein over 1 3 hours.

      They will be monitored at the clinic for 6 hours after the infusion. They will have
      additional blood draws.

      Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each
      visit they will be evaluated and have blood and urine tests.
    

Eligibility criteria:

        -  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