<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/NCT01723241</url>
  </required_header>
  <id_info>
    <org_study_id>XAF5 A1</org_study_id>
    <nct_id>NCT01723241</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers</brief_title>
  <official_title>A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose Study to Assess the Safety and Tolerability of XAF5 Gel Applied to the Skin of Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Topokine Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Topokine Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when&#xD;
      applied to the skin of healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>XAF5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XAF5, concentration A</intervention_name>
    <arm_group_label>XAF5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XAF5, concentration B</intervention_name>
    <arm_group_label>XAF5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XAF5, concentration C</intervention_name>
    <arm_group_label>XAF5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Must understand and provide informed consent&#xD;
&#xD;
          -  Skin upon which a reaction would be visible&#xD;
&#xD;
          -  Body weight &gt;= 70 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active skin disease&#xD;
&#xD;
          -  History of skin hypersensitivity&#xD;
&#xD;
          -  Clinically significant abnormality on physical exam, ECG, or laboratory tests&#xD;
&#xD;
          -  Positive test for HIV, Hepatitis B, or Hepatitis C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S. Singer, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Topokine Therapeutics</affiliation>
  </overall_official>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>January 9, 2016</last_update_submitted>
  <last_update_submitted_qc>January 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>volunteers</keyword>
  <!-- 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/NCT01723241
org study id: XAF5 A1
nct id: NCT01723241
lead sponsor: 
has dmc: No
This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when
      applied to the skin of healthy volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
arm group label: XAF5
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: XAF5, concentration A
arm group label: XAF5
intervention type: Drug
intervention name: XAF5, concentration B
arm group label: XAF5
intervention type: Drug
intervention name: XAF5, concentration C
arm group label: XAF5
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael S. Singer, MD, PhD
role: Study Director
affiliation: Topokine Therapeutics
responsible party type: Sponsor