<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/NCT03301870</url>
  </required_header>
  <id_info>
    <org_study_id>ATx201-006</org_study_id>
    <nct_id>NCT03301870</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers</brief_title>
  <official_title>A Single-Site Study To Evaluate The Irritation Potential Of Topically Applied ATx201 In Healthy Human Volunteers on Intact and Abraded Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNION therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNION 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 is a Phase I single-site study to evaluate the irritation potential of topically applied&#xD;
      ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201&#xD;
      GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six&#xD;
      (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to&#xD;
      complete the study. The test articles will be applied to the upper back of the subjects&#xD;
      during the study, and the placement of the test articles will be randomized. Abraded skin&#xD;
      will be induced using sequential tape stripping.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">November 6, 2017</completion_date>
  <primary_completion_date type="Actual">November 6, 2017</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>
    <intervention_model_description>the assignment of the test articles to the test sites will be randomized. Each &quot;arm&quot; is a different patch of skin on the same study participant</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative Irritation Scores</measure>
    <time_frame>21 days</time_frame>
    <description>the sum of the combined Dermal response and Other Effects Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of combined Dermal response and Other Effects Score &gt;=3</measure>
    <time_frame>21 days</time_frame>
    <description>Total number of days with a combined Dermal Response and Other Effects score of 3 or more for each test article</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Test Article Discontunation</measure>
    <time_frame>21 days</time_frame>
    <description>Number of subjects, by test article, where a test article was discontinued due to an unacceptable degree of irritation, or who experienced symptomatic intolerable irritation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to test article discontinuation</measure>
    <time_frame>21 days</time_frame>
    <description>Number of days until sufficient irritation occurred to preclude repeat application to the same site, or who experienced symptomatic intolerable irritation</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Irritation Potential of Topic Agent</condition>
  <arm_group>
    <arm_group_label>ATx201 GEL, 2% - intact skin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATx201 GEL, 2% applied intact skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 GEL, 4% - intact skin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATx201 GEL, 4% applied to intact skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 GEL, 2% - abraded skin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATx201 GEL, 2% applied to abraded skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 GEL, 4% - abraded skin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATx201 GEL, 4% applied to abraded skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 GEL Placebo - intact skin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ATx201 GEL Placebo applied to intact skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 GEL Placebo - abraded skin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ATx201 GEL Placebo applied to abraded skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Irritant Control - intact skin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Negative (low) Irritant Control applied to intact skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Irritant Control - abraded skin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Negative (low) Irritant Control applied to abraded skin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Irritant Control - intact skin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Positive (high) Irritant Control applied to intact skin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATx201 Gel 2%</intervention_name>
    <description>2% active gel</description>
    <arm_group_label>ATx201 GEL, 2% - abraded skin</arm_group_label>
    <arm_group_label>ATx201 GEL, 2% - intact skin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATx201 Gel 4%</intervention_name>
    <description>4% active gel</description>
    <arm_group_label>ATx201 GEL, 4% - abraded skin</arm_group_label>
    <arm_group_label>ATx201 GEL, 4% - intact skin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Positive Control</intervention_name>
    <description>Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP</description>
    <arm_group_label>Positive Irritant Control - intact skin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Negative Control</intervention_name>
    <description>Water for Injection, USP</description>
    <arm_group_label>Negative Irritant Control - abraded skin</arm_group_label>
    <arm_group_label>Negative Irritant Control - intact skin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATx201 Placebo</intervention_name>
    <description>matching placebo gel</description>
    <arm_group_label>ATx201 GEL Placebo - abraded skin</arm_group_label>
    <arm_group_label>ATx201 GEL Placebo - intact skin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Judged by the Investigator to have no health conditions that would impact the safety&#xD;
             of the subject during participation.&#xD;
&#xD;
          -  Body Mass Index (BMI) to be no less than 19.0 and no greater than 36.0 kg/m²&#xD;
             (inclusive).&#xD;
&#xD;
          -  Demonstrates a Fitzpatrick skin score of I - IV&#xD;
&#xD;
          -  Female subjects must agree to use a medically acceptable contraceptive method&#xD;
&#xD;
          -  Willing to refrain from excessive consumption of sodium (&gt; 2,400 mg/day or &gt; 1&#xD;
             teaspoon equivalent/day) in food or beverage 48 hours prior to Day 1 through EOS&#xD;
             Visit.&#xD;
&#xD;
          -  Willing to shower using the same non-medicated soap/cleansers, and abstain from&#xD;
             excessive sun exposure (including tanning salons) from the Screening Visit through EOS&#xD;
             Visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any clinical investigational product within 30 days prior to Day 1 through EOS Visit&#xD;
&#xD;
          -  recent or current medical condition that, in the opinion of the Investigator, might&#xD;
             significantly affect an immunological response to topical ATx201 or compromise the&#xD;
             safety of the subject.&#xD;
&#xD;
          -  history of diabetes mellitus, clinically significant asthma (acceptable if no episode&#xD;
             within 5 years prior to Day 1), or currently diagnosed with hypertension or&#xD;
             circulatory disease.&#xD;
&#xD;
          -  use of any medication on a regular basis within 14 days prior to Day 1 through EOS&#xD;
             that could change peripheral blood flow, with the exception of any prescribed birth&#xD;
             control method or hormone replacement therapy.&#xD;
&#xD;
          -  use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other&#xD;
             than Vitamin A at normal dietary amounts) within 14 days prior to the Screening Visit&#xD;
             through EOS Visit.&#xD;
&#xD;
          -  intending to start, stop, or change the dose of any prescription or over-the-counter&#xD;
             (OTC) medication within 48 hours prior to Day 1 through EOS Visit.&#xD;
&#xD;
          -  use of any prescription or OTC topical medications on the upper back within 30 days&#xD;
             prior to Day 1 through EOS Visit.&#xD;
&#xD;
          -  history of sensitivity/allergy to any ingredients found in the ATx201 formulation or&#xD;
             has a history of adverse reactions to topical medications.&#xD;
&#xD;
          -  significant history of allergy to soaps, lotions, emollients, ointments, creams,&#xD;
             cosmetics, adhesives, or latex.&#xD;
&#xD;
          -  history of significant skin conditions or disorders such as psoriasis, atopic&#xD;
             dermatitis, etc.&#xD;
&#xD;
          -  history of significant dermatologic cancers, for example, melanoma or squamous cell&#xD;
             carcinoma.&#xD;
&#xD;
          -  displays an obvious difference in skin color on the upper back or the presence of a&#xD;
             skin anomaly such as a recent sunburn, scratch, scar tissue, tattoo, or coloration&#xD;
             that would interfere with placement of test sites, their assessment, and their&#xD;
             potential response to the study drug or that could compromise the safety of the&#xD;
             subject.&#xD;
&#xD;
          -  smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1&#xD;
             through EOS Visit.&#xD;
&#xD;
          -  female who is pregnant, lactating, breastfeeding, or intends to become pregnant over&#xD;
             the course of the study.&#xD;
&#xD;
          -  history of drug or alcohol addiction or abuse within the past year.&#xD;
&#xD;
          -  caffeine intake greater than 500 mg per day (for example, 1 cup of coffee contains&#xD;
             approximately 85 mg of caffeine, tea approximately 25 mg, soft drinks up to 115 mg,&#xD;
             energy drinks 90 - 422 mg).&#xD;
&#xD;
          -  unwilling to abstain from energy drinks, alcohol, and excessive caffeine (&gt; 500&#xD;
             mg/day) for 48 hours prior to Day 1 through EOS Visit.&#xD;
&#xD;
          -  reports having donated blood or plasma within 48 hours prior to Day 1 through EOS&#xD;
             Visit.&#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>
  <overall_official>
    <last_name>Philippe Prokocimer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor CMO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bio-Kinetic Clinical Applications, LLC</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03301870
org study id: ATx201-006
nct id: NCT03301870
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase I single-site study to evaluate the irritation potential of topically applied
      ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201
      GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six
      (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to
      complete the study. The test articles will be applied to the upper back of the subjects
      during the study, and the placement of the test articles will be randomized. Abraded skin
      will be induced using sequential tape stripping.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: the assignment of the test articles to the test sites will be randomized. Each "arm" is a different patch of skin on the same study participant
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Cumulative Irritation Scores
time frame: 21 days
description: the sum of the combined Dermal response and Other Effects Score
measure: Time of combined Dermal response and Other Effects Score >=3
time frame: 21 days
description: Total number of days with a combined Dermal Response and Other Effects score of 3 or more for each test article
measure: Incidence of Test Article Discontunation
time frame: 21 days
description: Number of subjects, by test article, where a test article was discontinued due to an unacceptable degree of irritation, or who experienced symptomatic intolerable irritation
measure: Time to test article discontinuation
time frame: 21 days
description: Number of days until sufficient irritation occurred to preclude repeat application to the same site, or who experienced symptomatic intolerable irritation
arm group label: ATx201 GEL, 2% - intact skin
arm group type: Experimental
description: ATx201 GEL, 2% applied intact skin
arm group label: ATx201 GEL, 4% - intact skin
arm group type: Experimental
description: ATx201 GEL, 4% applied to intact skin
arm group label: ATx201 GEL, 2% - abraded skin
arm group type: Experimental
description: ATx201 GEL, 2% applied to abraded skin
arm group label: ATx201 GEL, 4% - abraded skin
arm group type: Experimental
description: ATx201 GEL, 4% applied to abraded skin
arm group label: ATx201 GEL Placebo - intact skin
arm group type: Placebo Comparator
description: ATx201 GEL Placebo applied to intact skin
arm group label: ATx201 GEL Placebo - abraded skin
arm group type: Placebo Comparator
description: ATx201 GEL Placebo applied to abraded skin
arm group label: Negative Irritant Control - intact skin
arm group type: Active Comparator
description: Negative (low) Irritant Control applied to intact skin
arm group label: Negative Irritant Control - abraded skin
arm group type: Active Comparator
description: Negative (low) Irritant Control applied to abraded skin
arm group label: Positive Irritant Control - intact skin
arm group type: Active Comparator
description: Positive (high) Irritant Control applied to intact skin
intervention type: Drug
intervention name: ATx201 Gel 2%
description: 2% active gel
arm group label: ATx201 GEL, 2% - abraded skin
arm group label: ATx201 GEL, 2% - intact skin
intervention type: Drug
intervention name: ATx201 Gel 4%
description: 4% active gel
arm group label: ATx201 GEL, 4% - abraded skin
arm group label: ATx201 GEL, 4% - intact skin
intervention type: Drug
intervention name: Positive Control
description: Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP
arm group label: Positive Irritant Control - intact skin
intervention type: Drug
intervention name: Negative Control
description: Water for Injection, USP
arm group label: Negative Irritant Control - abraded skin
arm group label: Negative Irritant Control - intact skin
intervention type: Drug
intervention name: ATx201 Placebo
description: matching placebo gel
arm group label: ATx201 GEL Placebo - abraded skin
arm group label: ATx201 GEL Placebo - intact skin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Prokocimer, MD
role: Study Director
affiliation: Sponsor CMO
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No