Clinical Trial: Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults
Brief 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 an
Detailed Summary:
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Type and frequency of adverse events [ Time Frame: During and up to 90 (+/-) days after study drug infusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetic profile [ Time Frame: 90 (+/-) days after study drug infusion ]
- Frequency and concentrations of antibodies caused by SAB-301 [ Time Frame: 90 (+/-) days after study drug infusion ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: May 28, 2016
Date Started: May 18, 2016
Date Completion: April 30, 2018
Last Updated: May 9, 2017
Last Verified: May 5, 2017
