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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.

Tracking Information
First Submitted Date  ICMJE July 10, 2020
First Posted Date  ICMJE July 14, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE July 29, 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
Number of participants having adverse events [ Time Frame: 90 days ]
Incidence and severity of other adverse events and severe adverse events (SAE)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • 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
  • 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
  • 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
  • Immune response elicited by SAB-176 [ Time Frame: 90 Days ]
    Measurement of rheumatoid factor through day 90
  • Concentration of subject anti-SAB-176 antibodies elicited by SAB-176 [ Time Frame: 90 Days ]
    Measurement of anti-SAB-176 antibodies through day 90
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants
Official Title  ICMJE A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Influenza Type A
  • Influenza Type B
  • Influenza
Intervention  ICMJE
  • Biological: SAB-176
    Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
  • Other: Normal Saline
    Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
Study Arms  ICMJE
  • Experimental: Cohort 1
    1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
    Intervention: Biological: SAB-176
  • Experimental: Cohort 2
    10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
    Intervention: Biological: SAB-176
  • Experimental: Cohort 3
    25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
    Intervention: Biological: SAB-176
  • Experimental: Cohort 4
    50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
    Intervention: Biological: SAB-176
  • Placebo Comparator: Cohort 5
    Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
    Intervention: Other: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2020)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cody Overstreet 512-747-4517 cody.overstreet@ppdi.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04471038
Other Study ID Numbers  ICMJE SAB-176-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party SAb Biotherapeutics, Inc.
Study Sponsor  ICMJE SAb Biotherapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca N Wood-Horrall, MD PPD
PRS Account SAb Biotherapeutics, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP