<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/NCT03239223</url>
  </required_header>
  <id_info>
    <org_study_id>ABI-1968-102</org_study_id>
    <nct_id>NCT03239223</nct_id>
  </id_info>
  <brief_title>Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection</brief_title>
  <official_title>A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antiva Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antiva Biosciences</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>
      This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical&#xD;
      precancerous lesions in adult women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Sequential Assignment</intervention_model>
    <intervention_model_description>Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL</measure>
    <time_frame>85 Days</time_frame>
    <description>Number of participants with Adverse Events related to treatment to determine MTD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.</measure>
    <time_frame>85 Days</time_frame>
    <description>Plasma concentrations of ABI-1968 over time to determine systemic exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.</measure>
    <time_frame>85 Days</time_frame>
    <description>Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>HSIL</condition>
  <condition>HSIL of Cervix</condition>
  <condition>High-Grade Squamous Intraepithelial Lesions</condition>
  <condition>High-grade Cervical Intraepithelial Neoplasia</condition>
  <condition>Human Papilloma Virus</condition>
  <condition>Cervical Cancer</condition>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <condition>Cervical Neoplasm</condition>
  <condition>Cervical Dysplasia</condition>
  <condition>CIN</condition>
  <arm_group>
    <arm_group_label>Dose 1 - Multiple Ascending Dose (MAD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2 - Multiple Ascending Dose (MAD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABI-1968</intervention_name>
    <description>Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts</description>
    <arm_group_label>Dose 1 - Multiple Ascending Dose (MAD)</arm_group_label>
    <arm_group_label>Dose 2 - Multiple Ascending Dose (MAD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, 25 to 50 years old.&#xD;
&#xD;
          -  Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy&#xD;
             with no evidence of invasive cancer in any specimen and must be p16+.&#xD;
&#xD;
          -  Able and willing to abstain from sexual intercourse for 48 hours prior to first dose&#xD;
             and 2 days after each dose.&#xD;
&#xD;
          -  Generally experiencing regular menstrual cycles, unless using long-acting reversible&#xD;
             contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, plan to become pregnant in the next 4 months, or lactating&#xD;
             females.&#xD;
&#xD;
          -  History of cancer, except basal cell or squamous cell carcinoma of the skin.&#xD;
&#xD;
          -  History of genital herpes with &gt; 3 outbreaks per year, or active non-HPV vaginal&#xD;
             infection.&#xD;
&#xD;
          -  Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.&#xD;
&#xD;
          -  History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of&#xD;
             CIN, or hysterectomy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>84304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</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>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Papilloma</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <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/NCT03239223
org study id: ABI-1968-102
nct id: NCT03239223
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical
      precancerous lesions in adult women.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
time frame: 85 Days
description: Number of participants with Adverse Events related to treatment to determine MTD
measure: Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
time frame: 85 Days
description: Plasma concentrations of ABI-1968 over time to determine systemic exposure
measure: Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
time frame: 85 Days
description: Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses
arm group label: Dose 1 - Multiple Ascending Dose (MAD)
arm group type: Experimental
description: ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
arm group label: Dose 2 - Multiple Ascending Dose (MAD)
arm group type: Experimental
description: ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
intervention type: Drug
intervention name: ABI-1968
description: Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
arm group label: Dose 1 - Multiple Ascending Dose (MAD)
arm group label: Dose 2 - Multiple Ascending Dose (MAD)
criteria: 
gender: Female
gender based: Yes
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: United States
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Papilloma
mesh term: Uterine Cervical Dysplasia
sharing ipd: No