<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/NCT03239379</url>
  </required_header>
  <id_info>
    <org_study_id>BNZ1-CT-102</org_study_id>
    <nct_id>NCT03239379</nct_id>
  </id_info>
  <brief_title>A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects</brief_title>
  <official_title>A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioniz Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celerion</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bioniz Therapeutics</source>
  <oversight_info>
    <has_dmc>No</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>
      This study is a single-center, randomized, single-blind, placebo (PBO)-controlled,&#xD;
      multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1&#xD;
      administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week&#xD;
      (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be&#xD;
      enrolled in the trial. Participants will be followed for 4 weeks after the last dose for&#xD;
      safety monitoring, and collection of PK and PD samples.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">March 8, 2018</completion_date>
  <primary_completion_date type="Actual">February 15, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Single-blind, placebo-controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence, severity and relationship of treatment-emergent adverse events</measure>
    <time_frame>8 weeks</time_frame>
    <description>general safety evaluation by principal investigator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>single-dose and steady state Cmax</measure>
    <time_frame>8 weeks</time_frame>
    <description>plasma concentrations collected at multiple times after the first and last doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>single-dose and steady state AUC0-t</measure>
    <time_frame>8 weeks</time_frame>
    <description>plasma concentrations collected at multiple times after the first and last doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state Elimination half-life (t1/2)</measure>
    <time_frame>8 weeks</time_frame>
    <description>plasma concentrations collected at multiple times after the last dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for Regulatory T-cells (Tregs)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Flow cytometry of PBMCs at multiple time points post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for Natural Killer Cells</measure>
    <time_frame>8 weeks</time_frame>
    <description>Flow cytometry of PBMCs at multiple time points post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for CD8+ central memory T-cells (Tcm)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Flow cytometry of PBMCs at multiple time points post dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Safety and Tolerability in Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BNZ132-1-40</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEGylated BNZ-1 for Injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BNZ132-1-40</intervention_name>
    <description>Injectable peptide antagonist of IL-2, IL-9 and IL-15</description>
    <arm_group_label>BNZ132-1-40</arm_group_label>
    <other_name>BNZ-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal Saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Non-smoker.&#xD;
&#xD;
          2. Weight ≤100 kg (due to drug supply limitations).&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥19 and &lt;35 kg/m2.&#xD;
&#xD;
          4. Healthy as determined by medical evaluation including medical history, physical&#xD;
             examination, clinical laboratory tests, vital signs (pulse rate, blood pressure,&#xD;
             respiratory rate), and ECG.&#xD;
&#xD;
          5. Willing and able to consent and participate in the study.&#xD;
&#xD;
          6. Subject agrees not to receive any other investigational product or therapy while&#xD;
             participating in this study.&#xD;
&#xD;
          7. Agrees to use adequate effective birth control methods prior to, during and for 30&#xD;
             days after the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine,&#xD;
             renal, or other major systemic disease making implementation of the protocol or&#xD;
             interpretation of the study results difficult, or that would put the subject at risk&#xD;
             by participating in the study in the opinion of the Investigator.&#xD;
&#xD;
          2. History of cancer (except basal cell and in situ squamous cell carcinomas of the skin&#xD;
             that have been excised and resolved).&#xD;
&#xD;
          3. History of or currently active primary or secondary immunodeficiency.&#xD;
&#xD;
          4. Known active bacterial, viral, fungal, mycobacterial infection, or other infection&#xD;
             (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal&#xD;
             infection of nail beds, minor upper respiratory tract infection, and minor skin&#xD;
             conditions]), or any major episode of infection that required hospitalization or&#xD;
             treatment with IV antibiotics within 30 days of screening or oral antibiotics within&#xD;
             14 days prior to screening.&#xD;
&#xD;
          5. Subject has received other investigational products or therapy in the past 30 days&#xD;
             prior to study drug administration.&#xD;
&#xD;
          6. Serologic evidence of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.&#xD;
&#xD;
          7. Subject has received an immunization within 14 days prior to study drug&#xD;
             administration.&#xD;
&#xD;
          8. History of alcohol or drug abuse within 1 year prior to screening.&#xD;
&#xD;
          9. Subject requires the ongoing use of prescription medication other than oral&#xD;
             contraceptives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A Frohna, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bioniz Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>May 12, 2018</last_update_submitted>
  <last_update_submitted_qc>May 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cytokine inhibitor</keyword>
  <keyword>IL-2</keyword>
  <keyword>IL-9</keyword>
  <keyword>IL-15</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03239379
org study id: BNZ1-CT-102
nct id: NCT03239379
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is a single-center, randomized, single-blind, placebo (PBO)-controlled,
      multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1
      administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week
      (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be
      enrolled in the trial. Participants will be followed for 4 weeks after the last dose for
      safety monitoring, and collection of PK and PD samples.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Single-blind, placebo-controlled
measure: Incidence, severity and relationship of treatment-emergent adverse events
time frame: 8 weeks
description: general safety evaluation by principal investigator
measure: single-dose and steady state Cmax
time frame: 8 weeks
description: plasma concentrations collected at multiple times after the first and last doses
measure: single-dose and steady state AUC0-t
time frame: 8 weeks
description: plasma concentrations collected at multiple times after the first and last doses
measure: Steady-state Elimination half-life (t1/2)
time frame: 8 weeks
description: plasma concentrations collected at multiple times after the last dose
measure: Change from baseline for Regulatory T-cells (Tregs)
time frame: 8 weeks
description: Flow cytometry of PBMCs at multiple time points post dose
measure: Change from baseline for Natural Killer Cells
time frame: 8 weeks
description: Flow cytometry of PBMCs at multiple time points post dose
measure: Change from baseline for CD8+ central memory T-cells (Tcm)
time frame: 8 weeks
description: Flow cytometry of PBMCs at multiple time points post dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal saline
arm group label: BNZ132-1-40
arm group type: Experimental
description: PEGylated BNZ-1 for Injection
intervention type: Drug
intervention name: BNZ132-1-40
description: Injectable peptide antagonist of IL-2, IL-9 and IL-15
arm group label: BNZ132-1-40
other name: BNZ-1
intervention type: Drug
intervention name: Placebo
description: Normal Saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul A Frohna, MD, PhD
role: Study Director
affiliation: Bioniz Therapeutics, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No