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

Completed · Phase 1 · Has a placebo group

Conditions studied: Middle East Respiratory Syndrome Coronavirus

In brief

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.

Key facts

Study ID

NCT02788188

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

38

Starts

2016-05-28

Expected to finish

2018-04-30

Last updated by the study team

2018-06-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any history of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)
• Any history of allergy, anaphylaxis, or severe reaction to IGIV or human blood products
• Any chronic medical problem that requires daily oral medications (except Tylenol, ibuprofen, oral contraceptives, vitamins, and seasonal allergy medications).
• History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope
• Subjects that have had confirmed MERS
• Women who are breast-feeding
• Positive urine or serum pregnancy test
• 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.
• 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.
• Abnormal urinalysis
• defined as any clinically significant baseline Grade 1 or greater toxicity--evaluating only protein, and RBCs
• Positive rheumatoid factor
• IgA deficiency (defined as IgA < 7 mg/dL)
• 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
• Participation in any other research study for 30 days after study drug administration
• Receipt of blood products within 2 months prior to study drug administration (i.e. Day 0)
• Receipt of any vaccination within 30 days prior to study drug administration (i.e. Day 0)
• 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

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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