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Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471038
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
SAb Biotherapeutics, Inc.

Brief Summary:
Influenza causes substantial morbidity and mortality worldwide despite available antivirals and vaccines. SAB Biotherapeutics, Inc. has developed SAB-176, an anti-influenza human immunoglobulin (transchromosomic [Tc] bovine-derived) intravenous therapeutic to treat past and current strains of Type A Influenza and Type B Influenza. This study will evaluate the safety, tolerability, and pharmacokinetics of SAB-176 in healthy participants.

Condition or disease Intervention/treatment Phase
Influenza Type A Influenza Type B Influenza Biological: SAB-176 Other: Normal Saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Cohort 1
1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
Biological: SAB-176
Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)

Experimental: Cohort 2
10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
Biological: SAB-176
Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)

Experimental: Cohort 3
25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
Biological: SAB-176
Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)

Experimental: Cohort 4
50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
Biological: SAB-176
Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)

Placebo Comparator: Cohort 5
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Other: Normal Saline
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm




Primary Outcome Measures :
  1. Number of participants having adverse events [ Time Frame: 90 days ]
    Incidence and severity of other adverse events and severe adverse events (SAE)


Secondary Outcome Measures :
  1. Measurement of Serum SAB-176 Titers [ Time Frame: 90 Days ]
    Measurement of Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90

  2. Assessment of the PD of SAB-176 administered Intravenously [ Time Frame: 90 Days ]
    Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90

  3. Ability of serum SAB-176 levels to neutralize Influenza to day 90 [ Time Frame: 90 Days ]
    Serum levels of SAB-176 using microneutralization (MN) assay through day 90

  4. Immune response elicited by SAB-176 [ Time Frame: 90 Days ]
    Measurement of rheumatoid factor through day 90

  5. Concentration of subject anti-SAB-176 antibodies elicited by SAB-176 [ Time Frame: 90 Days ]
    Measurement of anti-SAB-176 antibodies through day 90



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥18 years and ≤60 years
  2. Body mass index (BMI) of 19-32 kg/m2
  3. Subjects must have values in normal ranges for basic labs (i.e., CBC, PT/INR, Chem-7, and LFTs), unless deemed not clinically significant by the PI.
  4. Estimated glomerular filtration rate ≥90 mL/min at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  5. Subjects must agree to:

Not take any prescription or over-the-counter (OTC) medications with the exception of acetaminophen, ibuprofen, vitamins, seasonal allergy medications, and/or contraceptive medications, or others unless approved by the study investigator, for a period 7 days prior to study drug administration (i.e., Day 0). Use 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.

Neither females or males should donate oocysts or sperm for use in artificial insemination through 60 days after the last dose of study drug.

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 IVIg or human blood products
  3. Any chronic medical problem/condition that require medications needed to maintain the subject's health. Exceptions to this restriction can be allowed for minor health conditions that are treated with Tylenol, over-the-counter non-steroidal anti-inflammatories, vitamins, seasonal allergy medications, or oral/transdermal/IUD contraceptives, etc. The study investigator will make a determination to exclude a subject based upon their medical history and the type and frequency of the drug substance.
  4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope
  5. Abnormal clinically significant 12-lead electrocardiogram (ECG), per PI discretion
  6. Subjects who have been laboratory confirmed or clinically diagnosed with influenza within seven days prior to infusion (by subject history) will be deferred from infusion. Any subject with signs and symptoms of an active respiratory infection on the day of infusion will be deferred until the infection is cleared in the opinion of the investigator. Subjects that present with an active upper respiratory infection on the day of infusion will be tested with an FDA licensed Influenza A/B Antigen Test. Signs and symptoms constituting an upper respiratory infection include cough, sore throat, or rhinorrhea with or without fever.
  7. Enrollment will be delayed for all patients who have other intercurrent infections (e.g., gastroenteritis, abscess, etc.).
  8. Women who are breast-feeding
  9. Positive urine or serum pregnancy test
  10. Positive urine drug screen (UDS)
  11. Clinically significant results, including laboratory results, as determined by study investigator
  12. Positive rheumatoid factor
  13. IgA deficiency (defined as IgA less than 7 mg/dL)
  14. 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
  15. Participation in any other research study until the completion of the study
  16. Receipt of blood products within 2 months prior to study drug administration (i.e.Day 0)
  17. Receipt of any vaccination within 30 days prior to study drug administration (i.e.Day 0)
  18. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471038


Contacts
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Contact: Cody Overstreet 512-747-4517 cody.overstreet@ppdi.com

Locations
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United States, Texas
PPD, Phase 1 Clinic Recruiting
Austin, Texas, United States, 78744
Contact: Cody Overstreet    512-747-4517    cody.overstreet@ppdi.com   
Principal Investigator: Rebecca N Wood-Horrall, MD         
Sponsors and Collaborators
SAb Biotherapeutics, Inc.
Investigators
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Principal Investigator: Rebecca N Wood-Horrall, MD PPD
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Responsible Party: SAb Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04471038    
Other Study ID Numbers: SAB-176-101
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
Supporting Materials: Study Protocol
Time Frame: Starting 6 months after publication and ending 36 months following article publication
Access Criteria: Anyone who wishes to access the data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases