At a glance
ClinicalIndex Comparison Record- ✓Age 18–60 years
- ✓BMI 19–32 kg/m²
- ✓Estimated glomerular filtration rate ≥70 mL/min (CKD-EPI)
- ✓Willing to avoid most medications (except acetaminophen, ibuprofen, vitamins, seasonal allergy medications, contraceptives) for 7 days before study drug
- ✕History of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)
- ✕History of allergy, anaphylaxis, or severe reaction to IGIV or human blood products
- ✕Chronic medical condition requiring daily oral medications (except Tylenol, ibuprofen, oral contraceptives, vitamins, seasonal allergy medications)
- ✕History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating SAB-301 and Normal (9%) Saline for Middle East Respiratory Syndrome Coronavirus. Completed, enrolled 38 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.