Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults
2 other identifiers
interventional
38
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2016
CompletedStudy Start
First participant enrolled
May 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedResults Posted
Study results publicly available
June 12, 2018
CompletedJune 12, 2018
July 1, 2017
1.9 years
May 28, 2016
May 14, 2018
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Having Adverse Events
Number of participants who experienced an adverse event
90 days
Study Arms (7)
Cohort 1
EXPERIMENTALCohort 1: 1mg/kg SAB-301 in normal (9%) saline; concentration 1mg/mL (0.1%)
Placebo
PLACEBO COMPARATORNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Cohort 2
EXPERIMENTALCohort 2: 2.5 mg/kg SAB-301 in normal (9%) saline; concentration 1mg/mL (0.1%)
Cohort 3
EXPERIMENTALCohort 3: 5mg/kg SAB-301 in normal (9%) saline; concentration 4mg/mL (0.4%)
Cohort 4
EXPERIMENTALCohort 4: 10mg/kg SAB-301 in normal (9%) saline; concentration 4mg/mL (0.4%)
Cohort 5
EXPERIMENTALCohort 5: 20mg/kg SAB-301 in normal (9%) saline; concentration 20mg/mL (2%)
Cohort 6
EXPERIMENTALCohort 6: 50mg/kg SAB-301 in normal (9%) saline; concentration 20mg/mL (2%)
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.
Eligibility Criteria
You may qualify if:
- 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.
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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
Luke T, Wu H, Zhao J, Channappanavar R, Coleman CM, Jiao JA, Matsushita H, Liu Y, Postnikova EN, Ork BL, Glenn G, Flyer D, Defang G, Raviprakash K, Kochel T, Wang J, Nie W, Smith G, Hensley LE, Olinger GG, Kuhn JH, Holbrook MR, Johnson RF, Perlman S, Sullivan E, Frieman MB. Human polyclonal immunoglobulin G from transchromosomic bovines inhibits MERS-CoV in vivo. Sci Transl Med. 2016 Feb 17;8(326):326ra21. doi: 10.1126/scitranslmed.aaf1061.
PMID: 26888429BACKGROUNDSteinberger BA, Ford SM, Coleman TA. Intravenous immunoglobulin therapy results in post-infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia. Am J Hematol. 2003 Jun;73(2):97-100. doi: 10.1002/ajh.10325.
PMID: 12749010BACKGROUNDBeigel JH, Voell J, Kumar P, Raviprakash K, Wu H, Jiao JA, Sullivan E, Luke T, Davey RT Jr. Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study. Lancet Infect Dis. 2018 Apr;18(4):410-418. doi: 10.1016/S1473-3099(18)30002-1. Epub 2018 Jan 9.
PMID: 29329957RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Davey, Richard
- Organization
- National Institute of Allergy and Infectious Diseases
Study Officials
- PRINCIPAL INVESTIGATOR
Richard T Davey, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2016
First Posted
June 2, 2016
Study Start
May 28, 2016
Primary Completion
April 10, 2018
Study Completion
April 30, 2018
Last Updated
June 12, 2018
Results First Posted
June 12, 2018
Record last verified: 2017-07