<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/NCT04415671</url>
  </required_header>
  <id_info>
    <org_study_id>ADA-AD-214-1A</org_study_id>
    <nct_id>NCT04415671</nct_id>
  </id_info>
  <brief_title>Phase 1 Safety, Tolerability, PK &amp; PD Study of AD-214 Administered to Healthy Volunteers</brief_title>
  <official_title>A Phase 1, Dose-escalating Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of AD-214 When Administered Intravenously to Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdAlta Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AdAlta Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety,&#xD;
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when&#xD;
      administered to healthy volunteers (HVs). The study in HVs will be a randomized, double&#xD;
      blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD)&#xD;
      (Part B) study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">February 8, 2022</completion_date>
  <primary_completion_date type="Actual">October 21, 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>
    <masking_description>SAD Part A in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) MAD Part B in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment</measure>
    <time_frame>SAD Part A- 28 days. MAD Part B - 57 days</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Part A- AD-214 SAD in Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A-Placebo SAD in Healthy Volunteers</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B-AD-214 MAD in Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B-Placebo MAD in Healthy Volunteers</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AD-214</intervention_name>
    <description>AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.</description>
    <arm_group_label>Part A- AD-214 SAD in Healthy Volunteers</arm_group_label>
    <arm_group_label>Part B-AD-214 MAD in Healthy Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Part A-Placebo SAD in Healthy Volunteers</arm_group_label>
    <arm_group_label>Part B-Placebo MAD in Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must provide signed informed consent prior to study entry and agree to adhere to all&#xD;
             study protocol requirements.&#xD;
&#xD;
          2. Maximum weight of 100 kg at the time of consent and body mass index (BMI) &gt;18 and &lt; 30&#xD;
             kg/m2 (inclusive)&#xD;
&#xD;
          3. Must agree to abstain from alcohol intake from 48 hours before first study drug&#xD;
             administration through to final study visit&#xD;
&#xD;
          4. Must agree to abstain from smoking from 48 hours before first study drug&#xD;
             administration through to final study visit&#xD;
&#xD;
          5. Must have a negative urine drug screen and cotinine test, and alcohol breath test at&#xD;
             Screening and on Day -1 (admission).&#xD;
&#xD;
          6. Must agree to use highly effective, double barrier contraception (both male and female&#xD;
             partners) at least 30 days prior to dosing on day 1, during the study AND for 90 days&#xD;
             following completion of dosing&#xD;
&#xD;
          7. Male participants must refrain from sperm donation from start of study and for 90 days&#xD;
             after last dose of AD-214&#xD;
&#xD;
          8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at&#xD;
             Screening and a negative urine pregnancy test on Day -1.&#xD;
&#xD;
          9. Participants must be in good general health, with no significant medical history, and&#xD;
             no clinically significant abnormalities on physical examination at Screening, and/or&#xD;
             before administration of the initial dose of study drug.&#xD;
&#xD;
         10. Participants must have clinical laboratory values within normal range or &lt; 1.5 x upper&#xD;
             limit of normal (ULN) as specified by the testing laboratory at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received any Investigational Medicinal Product (IMP) within 30 days (4 months if the&#xD;
             previous drug was a new chemical entity) or 5 half-lives prior to Screening&#xD;
&#xD;
          2. Received an investigational vaccine within 6 months, a live attenuated vaccine within&#xD;
             60 days or a registered vaccine within 30 days prior to the first dose of the&#xD;
             investigational product.&#xD;
&#xD;
          3. Received blood products within 1 month prior to Screening.&#xD;
&#xD;
          4. Blood donation or significant blood loss (&gt; 450 mL) within 60 days prior to the first&#xD;
             administration of investigational product&#xD;
&#xD;
          5. Plasma donation within 7 days prior to the first administration of investigational&#xD;
             product.&#xD;
&#xD;
          6. A bleeding disorder diagnosed by a doctor or significant bruising or bleeding&#xD;
             difficulties with blood draws.&#xD;
&#xD;
          7. Known history of Human Immunodeficiency Virus (HIV) or HIV antibody positive.&#xD;
&#xD;
          8. Hepatitis B surface Antigen (HBsAg) positive or Hepatitis B Virus (HBV) polymerase&#xD;
             chain reaction (PCR) positivity. Hepatitis C Virus (HCV) antibody positive or HCV PCR&#xD;
             positivity.&#xD;
&#xD;
          9. Any clinically significant abnormality at Screening determined by medical history,&#xD;
             physical examination, blood chemistry, hematology, coagulation, urinalysis and 12-lead&#xD;
             electrocardiogram (ECG).&#xD;
&#xD;
         10. A history of or current clinically significant gastrointestinal, hepatic, renal,&#xD;
             cardiovascular, respiratory (apart from ILD), endocrine, oncological,&#xD;
             immunodeficiency, neurological, metabolic, hematological, autoimmune or social or&#xD;
             psychiatric condition which in the investigator's opinion may interfere with the study&#xD;
             objectives, may put the participant at risk or may make the participant unsuitable for&#xD;
             participation in the study.&#xD;
&#xD;
         11. Surgery within the past 3 months prior to the first study drug administration&#xD;
             determined by the PI to be clinically relevant.&#xD;
&#xD;
         12. History or presence of alcohol or drug abuse&#xD;
&#xD;
         13. Females who are pregnant or lactating.&#xD;
&#xD;
         14. Use of any prescription or over the counter medication (with the exception of&#xD;
             paracetamol and contraceptives) within 7 days of first study drug administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Scientia Clinical Research Ltd</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMAX Clinical Research Pty Ltd</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <!-- 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/NCT04415671
org study id: ADA-AD-214-1A
nct id: NCT04415671
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety,
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when
      administered to healthy volunteers (HVs). The study in HVs will be a randomized, double
      blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD)
      (Part B) study.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: SAD Part A in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) MAD Part B in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment
time frame: SAD Part A- 28 days. MAD Part B - 57 days
arm group label: Part A- AD-214 SAD in Healthy Volunteers
arm group type: Experimental
arm group label: Part A-Placebo SAD in Healthy Volunteers
arm group type: Placebo Comparator
arm group label: Part B-AD-214 MAD in Healthy Volunteers
arm group type: Experimental
arm group label: Part B-Placebo MAD in Healthy Volunteers
arm group type: Placebo Comparator
intervention type: Biological
intervention name: AD-214
description: AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.
arm group label: Part A- AD-214 SAD in Healthy Volunteers
arm group label: Part B-AD-214 MAD in Healthy Volunteers
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Part A-Placebo SAD in Healthy Volunteers
arm group label: Part B-Placebo MAD in Healthy Volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial