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A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults

Trial Profile

A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Apr 2019

At a glance

  • Drugs MERS monoclonal antibody (Primary)
  • Indications Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions
  • Most Recent Events

    • 14 May 2018 Status changed from active, no longer recruiting to completed.
    • 10 Jan 2018 According to an SAB Biotherapeutics media release, John H. Beigel is the principal investigator of this trial.
    • 10 Jan 2018 According to an SAB Biotherapeutics media release, results from this trial have been published in The Lancet Infectious Diseases.

Trial Overview

Purpose

This trial will investigate safety of Middle East respiratory syndrome coronavirus antibody.

Primary Endpoints

Number of Participants Having Adverse Events

description: Number of participants who experienced an adverse event
time_frame: 90 days

Other Endpoints

Pharmacokinetic profile

safety_issue: Yes
time_frame: 90 (+/-) days after study drug infusion

Frequency and concentrations of antibodies caused by SAB-301

safety_issue: Yes
time_frame: 90 (+/-) days after study drug infusion [1]

Diseases Treated

Indication Qualifiers Patient Segments
Middle East respiratory syndrome coronavirus treatment -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 70

    Actual: 38

  • Sex male & female
  • Age Group 18-60 years; adult

Patient Inclusion Criteria

- 1. Age greater than or equal to 18 years and less than or equal to 60 years 2. Body mass index (BMI) of 19-32 kg/m(2) 3. Estimated glomerular filtration rate greater than or equal to 70 mL/min at screening, calculated using the CKD-EPI formula 4. 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) 5. 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.

Patient Exclusion Criteria

1. Any history of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin) 2. Any history of allergy, anaphylaxis, or severe reaction to IGIV or human blood products 3. Any chronic medical problem that requires daily oral medications (except Tylenol, ibuprofen, oral contraceptives, vitamins, and seasonal allergy medications). 4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope 5. Subjects that have had confirmed MERS 6. Women who are breast-feeding 7. Positive urine or serum pregnancy test 8. 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. 9. 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. 10. Abnormal urinalysis -defined as any clinically significant baseline Grade 1 or greater toxicity--evaluating only protein, and RBCs 11. Positive rheumatoid factor 12. IgA deficiency (defined as IgA < 7 mg/dL) 13. 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 14. Participation in any other research study for 30 days after study drug administration 15. Receipt of blood products within 2 months prior to study drug administration (i.e. Day 0) 16. Receipt of any vaccination within 30 days prior to study drug administration (i.e. Day 0) 17. 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

Trial Details

Identifiers

Identifier Owner
NCT02788188 ClinicalTrials.gov: US National Institutes of Health
160119 -
16I0119 -

Organisations

  • Affiliations SAB Biotherapeutics

Trial Dates

  • Initiation Dates

    Actual : 28 May 2016

  • Primary Completion Dates

    Planned : 10 Apr 2018

    Actual : 10 Apr 2018

  • End Dates

    Planned : 30 Apr 2017

    Actual : 30 Apr 2018

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
MERS monoclonal antibodyPrimary Drug Intravenous Infusion

Cohort 1

Cohort 1: 1mg/kg SAB-301 in normal (9%) saline; concentration 1mg/mL (0.1%) Biological: SAB-301 (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.)

Cohort 2

Cohort 2: 2.5 mg/kg SAB-301 in normal (9%) saline; concentration 1mg/mL (0.1%) Biological: SAB-301 (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.)

Cohort 3

Cohort 3: 5mg/kg SAB-301 in normal (9%) saline; concentration 4mg/mL (0.4%) Biological: SAB-301 (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.)

Cohort 4

Cohort 4: 10mg/kg SAB-301 in normal (9%) saline; concentration 4mg/mL (0.4%) Biological: SAB-301 (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.)

Cohort 5

Cohort 5: 20mg/kg SAB-301 in normal (9%) saline; concentration 20mg/mL (2%) Biological: SAB-301 (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.)

Cohort 6

Cohort 6: 50mg/kg SAB-301 in normal (9%) saline; concentration 20mg/mL (2%) Biological: SAB-301 (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.)

Placebo

Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. Other: Normal (9%) Saline (Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Richard T Davey, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
-

Centres

Centre Name Location Trial Centre Country
National Institute of Allergy and Infectious Diseases (NIAID)
-
-
National Institutes of Health Clinical Center Bethesda, Maryland USA
Naval Medical Research Center
-
-
SAB Biotherapeutics, Inc
-
-

Trial History

Event Date Event Type Comment
25 Apr 2019 Other trial event Last checked against Clinicaltrials.gov record. Updated 25 Apr 2019
14 May 2018 Status change - completed Status changed from active, no longer recruiting to completed. Updated 19 Jun 2018
10 Jan 2018 Other trial event According to an SAB Biotherapeutics media release, John H. Beigel is the principal investigator of this trial. Updated 12 Jan 2018
10 Jan 2018 Results According to an SAB Biotherapeutics media release, results from this trial have been published in The Lancet Infectious Diseases. Updated 12 Jan 2018
09 May 2017 Other trial event Planned primary completion date changed from 30 Apr 2017 to 10 Apr 2018. Updated 16 May 2017
24 Jan 2017 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 02 Feb 2017
30 Nov 2016 Other trial event New source identified and integrated (ClinicalTrials.gov: NCT02788188). Updated 30 Nov 2016
24 Aug 2016 Other trial event According to SAB Biotherapeutics media release, this trial will be conducted by the National Institutes of Health (NIH). Updated 14 Sep 2016
11 Aug 2016 Other trial event According to a SAB Biotherapeutics media release, the clinical report expected end of Q1 2017. Updated 07 Sep 2016
24 May 2016 Status change - recruiting Status changed from planning to recruiting, as reported by a SAB Biotherapeutics media release. Updated 07 Sep 2016
02 Mar 2016 New trial record New trial record Updated 02 Mar 2016
17 Feb 2016 Other trial event According to a SAB Biotherapeutics media release, the company is planning to submit an initial new drug application for Phase I Clinical Trials to the U.S. Food and Drug Administration (FDA) in the first quarter of 2016. Updated 02 Mar 2016

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. SAB Biotherapeutics. First Treatment for MERS Appears Safe in NIH Phase I Clinical Trial. Media-Rel 2018;.

    Media Release
  3. SAB Biotherapeutics. SAB Biotherapeutics Announces Contract with BARDA to Advance First MERS Treatment. Media-Rel 2016;.

    Media Release
  4. SAB Biotherapeutics. SAB Biotherapeutics Produces New Human Antibody Treatment for MERS-CoV. Media-Rel 2016;.

    Media Release
  5. SAB Biotherapeutics. Phase I Clinical Trials Underway for First MERS Treatment. Media-Rel 2016;.

    Media Release
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