<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471038</url>
  </required_header>
  <id_info>
    <org_study_id>SAB-176-101</org_study_id>
    <nct_id>NCT04471038</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants</brief_title>
  <official_title>A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SAb Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SAb Biotherapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influenza causes substantial morbidity and mortality worldwide despite available antivirals&#xD;
      and vaccines. SAB Biotherapeutics, Inc. has developed SAB-176, an anti-influenza human&#xD;
      immunoglobulin (transchromosomic [Tc] bovine-derived) intravenous therapeutic to treat past&#xD;
      and current strains of Type A Influenza and Type B Influenza. This study will evaluate the&#xD;
      safety, tolerability, and pharmacokinetics of SAB-176 in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">April 19, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants having adverse events</measure>
    <time_frame>90 days</time_frame>
    <description>Incidence and severity of other adverse events and severe adverse events (SAE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of Serum SAB-176 Titers</measure>
    <time_frame>90 Days</time_frame>
    <description>Measurement of Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the PD of SAB-176 administered Intravenously</measure>
    <time_frame>90 Days</time_frame>
    <description>Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of serum SAB-176 levels to neutralize Influenza to day 90</measure>
    <time_frame>90 Days</time_frame>
    <description>Serum levels of SAB-176 using microneutralization (MN) assay through day 90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune response elicited by SAB-176</measure>
    <time_frame>90 Days</time_frame>
    <description>Measurement of rheumatoid factor through day 90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of subject anti-SAB-176 antibodies elicited by SAB-176</measure>
    <time_frame>90 Days</time_frame>
    <description>Measurement of anti-SAB-176 antibodies through day 90</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Influenza Type A</condition>
  <condition>Influenza Type B</condition>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SAB-176</intervention_name>
    <description>Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm</description>
    <arm_group_label>Cohort 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years and ≤60 years&#xD;
&#xD;
          2. Body mass index (BMI) of 19-32 kg/m2&#xD;
&#xD;
          3. Subjects must have values in normal ranges for basic labs (i.e., CBC, PT/INR, Chem-7,&#xD;
             and LFTs), unless deemed not clinically significant by the PI.&#xD;
&#xD;
          4. Estimated glomerular filtration rate ≥90 mL/min at screening, calculated using the&#xD;
             Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula&#xD;
&#xD;
          5. Subjects must agree to:&#xD;
&#xD;
        Not take any prescription or over-the-counter (OTC) medications with the exception of&#xD;
        acetaminophen, ibuprofen, vitamins, seasonal allergy medications, and/or contraceptive&#xD;
        medications, or others unless approved by the study investigator, for a period 7 days prior&#xD;
        to study drug administration (i.e., Day 0). Use one of the following in order to avoid&#xD;
        pregnancy: Females who are able to become pregnant (i.e., are not postmenopausal, have not&#xD;
        undergone surgical sterilization, and are sexually active with men) must agree to use at&#xD;
        least 2 effective forms of contraception from the date of the subject's signing of the&#xD;
        informed consent form through 60 days after the last dose of study drug. At least one of&#xD;
        the methods of contraception should be a barrier method.&#xD;
&#xD;
        Males who have not undergone surgical sterilization and are sexually active with women must&#xD;
        agree to use condoms plus have a partner use at least one additional effective form of&#xD;
        contraception from the date of the subject's signing of the informed consent form through&#xD;
        60 days after the last dose of study drug.&#xD;
&#xD;
        Neither females or males should donate oocysts or sperm for use in artificial insemination&#xD;
        through 60 days after the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any history of allergy, anaphylaxis, or severe reaction to beef products (including&#xD;
             milk and gelatin)&#xD;
&#xD;
          2. Any history of allergy, anaphylaxis, or severe reaction to IVIg or human blood&#xD;
             products&#xD;
&#xD;
          3. Any chronic medical problem/condition that require medications needed to maintain the&#xD;
             subject's health. Exceptions to this restriction can be allowed for minor health&#xD;
             conditions that are treated with Tylenol, over-the-counter non-steroidal&#xD;
             anti-inflammatories, vitamins, seasonal allergy medications, or oral/transdermal/IUD&#xD;
             contraceptives, etc. The study investigator will make a determination to exclude a&#xD;
             subject based upon their medical history and the type and frequency of the drug&#xD;
             substance.&#xD;
&#xD;
          4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained&#xD;
             syncope&#xD;
&#xD;
          5. Abnormal clinically significant 12-lead electrocardiogram (ECG), per PI discretion&#xD;
&#xD;
          6. Subjects who have been laboratory confirmed or clinically diagnosed with influenza&#xD;
             within seven days prior to infusion (by subject history) will be deferred from&#xD;
             infusion. Any subject with signs and symptoms of an active respiratory infection on&#xD;
             the day of infusion will be deferred until the infection is cleared in the opinion of&#xD;
             the investigator. Subjects that present with an active upper respiratory infection on&#xD;
             the day of infusion will be tested with an FDA licensed Influenza A/B Antigen Test.&#xD;
             Signs and symptoms constituting an upper respiratory infection include cough, sore&#xD;
             throat, or rhinorrhea with or without fever.&#xD;
&#xD;
          7. Enrollment will be delayed for all patients who have other intercurrent infections&#xD;
             (e.g., gastroenteritis, abscess, etc.).&#xD;
&#xD;
          8. Women who are breast-feeding&#xD;
&#xD;
          9. Positive urine or serum pregnancy test&#xD;
&#xD;
         10. Positive urine drug screen (UDS)&#xD;
&#xD;
         11. Clinically significant results, including laboratory results, as determined by study&#xD;
             investigator&#xD;
&#xD;
         12. Positive rheumatoid factor&#xD;
&#xD;
         13. IgA deficiency (defined as IgA less than 7 mg/dL)&#xD;
&#xD;
         14. Participation in another research study with receipt of any investigational drug&#xD;
             within 5 half-lives or 30 days, whichever is longer, prior to study drug&#xD;
             administration (i.e., Day 0) and until completion of the study&#xD;
&#xD;
         15. Participation in any other research study until the completion of the study&#xD;
&#xD;
         16. Receipt of blood products within 2 months prior to study drug administration (i.e.Day&#xD;
             0)&#xD;
&#xD;
         17. Receipt of any vaccination within 30 days prior to study drug administration (i.e.Day&#xD;
             0)&#xD;
&#xD;
         18. Any acute or chronic condition that, in the opinion of the Investigator, would limit&#xD;
             the subject's ability to complete and/or participate in this clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca N Wood-Horrall, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PPD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PPD, Phase 1 Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 25, 2021</last_update_submitted>
  <last_update_submitted_qc>October 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication and ending 36 months following article publication</ipd_time_frame>
    <ipd_access_criteria>Anyone who wishes to access the data.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471038
org study id: SAB-176-101
nct id: NCT04471038
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants having adverse events
time frame: 90 days
description: Incidence and severity of other adverse events and severe adverse events (SAE)
measure: Measurement of Serum SAB-176 Titers
time frame: 90 Days
description: Measurement of Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90
measure: Assessment of the PD of SAB-176 administered Intravenously
time frame: 90 Days
description: Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90
measure: Ability of serum SAB-176 levels to neutralize Influenza to day 90
time frame: 90 Days
description: Serum levels of SAB-176 using microneutralization (MN) assay through day 90
measure: Immune response elicited by SAB-176
time frame: 90 Days
description: Measurement of rheumatoid factor through day 90
measure: Concentration of subject anti-SAB-176 antibodies elicited by SAB-176
time frame: 90 Days
description: Measurement of anti-SAB-176 antibodies through day 90
arm group label: Cohort 1
arm group type: Experimental
description: 1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
arm group label: Cohort 2
arm group type: Experimental
description: 10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
arm group label: Cohort 3
arm group type: Experimental
description: 25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
arm group label: Cohort 4
arm group type: Experimental
description: 50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
arm group label: Cohort 5
arm group type: Placebo Comparator
description: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
intervention type: Biological
intervention name: SAB-176
description: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
intervention type: Other
intervention name: Normal Saline
description: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
arm group label: Cohort 5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca N Wood-Horrall, MD
role: Principal Investigator
affiliation: PPD
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
ipd info type: Study Protocol
ipd time frame: Starting 6 months after publication and ending 36 months following article publication
ipd access criteria: Anyone who wishes to access the data.