Phase 1
N=38
Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
Middle East Respiratory Syndrome Coronavirus
Bottom Line
View on ClinicalTrials.gov: NCT02788188 ↗Enrolled (actual)
38
Serious AEs
2.6%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants Having Adverse Events — 1; 2; 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- SAB-301 (Biological); Normal (9%) Saline (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Having Adverse Events |
1; 2; 2; 4; 7; 8 | — |
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:
- Age greater than or equal to 18 years and less than or equal to 60 years
- Body mass index (BMI) of 19-32 kg/m(2)
- Estimated glomerular filtration rate greater than or equal to 70 mL/min at screening, calculated using the CKD-EPI formula
- 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)
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT02788188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.