Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
Condition: Middle East Respiratory Syndrome Coronavirus
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The administration of convalescent plasma or hyperimmune immunoglobulin is often used for
      treatment of emerging infectious diseases. However, production of large quantities of
      anti-pathogen human plasma and/or immunoglobulin with high affinity and avidity antibodies
      currently requires donations by convalescent humans, a process that can limit availability
      for a number of reasons. One novel alternative source is transchromosomic (Tc) cattle that
      produce fully human polyclonal IgG (hIgG) de novo and mount a robust antibody immune response
      after vaccination.

      This study will evaluate the safety, tolerability, and immunogenicity of SAB-301, a fully
      human polyclonal anti-MERS IgG collected from transchromosomic cattle. Beginning with a low
      single-dose, subjects are randomized to receive either SAB-301 or a normal saline control,
      and evaluated on Study Days 1, 3, 7, 21, 42, and 90. The safety and tolerability is evaluated
      using symptoms, clinical laboratory tests, pharmacokinetics, and immunogenicity assays.
      Utilizing a series of stopping rules and a medical monitor, the dose will be escalated as
      safety and tolerability are established.
    

Intervention name(s): SAB-301; Normal (9%) Saline
Intervention type(s): Biological; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: First in Human; Middle East Respiratory Syndrome (MERS); Tc Bovine-Derived; Transchromosomic Cattle