<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/NCT03798561</url>
  </required_header>
  <id_info>
    <org_study_id>ASN008-101</org_study_id>
    <nct_id>NCT03798561</nct_id>
  </id_info>
  <brief_title>Study to Evaluate ASN008 Topical Gel (TG)</brief_title>
  <official_title>A Phase 1, Randomized, Double-Blind, Vehicle-Controlled Ascending Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASN008 Topical Gel in Healthy Volunteers and Subjects With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asana BioSciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asana 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 is an ascending dose escalation study to test the safety, tolerability and preliminary&#xD;
      efficacy of ASN008 TG in first-in-human subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and&#xD;
      tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in&#xD;
      cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be&#xD;
      determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate&#xD;
      dermatitis. Results from Part A and B will characterize safety, tolerability and&#xD;
      pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a&#xD;
      numerical rating scale (NRS) of pruritus at baseline and on Day 15.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">March 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</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>Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B)</measure>
    <time_frame>Part A: 14 days; Part B: 22 days</time_frame>
    <description>Analyze incidence of treatment-emergent adverse events (TEAE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculate area under the plasma concentration versus time curve (Part A and B)</measure>
    <time_frame>7 days and 16 days</time_frame>
    <description>A plot of the concentration of ASN008 in plasma over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate the Pharmacokinetic Half-life (Part A and B)</measure>
    <time_frame>7 days and 16 days</time_frame>
    <description>Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate the Pharmacokinetic maximum concentration (Part A and B)</measure>
    <time_frame>7 days and 16 days</time_frame>
    <description>Maximum concentration of ASN008 achieved after dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pruritus NRS in AD subjects (Part B)</measure>
    <time_frame>22 days</time_frame>
    <description>Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)</measure>
    <time_frame>22 days</time_frame>
    <description>Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)</measure>
    <time_frame>22 Days</time_frame>
    <description>5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema)</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <condition>Pruritus</condition>
  <condition>Dermatitis Eczema</condition>
  <arm_group>
    <arm_group_label>82 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>164 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>328 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>492 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASN008 TG TBD Cohort 1 or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASN008 TG TBD Cohort 2 or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASN008 TG TBD Cohort 3 or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASN008 TG</intervention_name>
    <description>ASN008 TG</description>
    <arm_group_label>164 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>328 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>492 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>82 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>ASN008 TG TBD Cohort 1 or Placebo</arm_group_label>
    <arm_group_label>ASN008 TG TBD Cohort 2 or Placebo</arm_group_label>
    <arm_group_label>ASN008 TG TBD Cohort 3 or Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo TG</intervention_name>
    <description>Placebo TG</description>
    <arm_group_label>164 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>328 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>492 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>82 µg/cm2 ASN008 TG or Placebo</arm_group_label>
    <arm_group_label>ASN008 TG TBD Cohort 1 or Placebo</arm_group_label>
    <arm_group_label>ASN008 TG TBD Cohort 2 or Placebo</arm_group_label>
    <arm_group_label>ASN008 TG TBD Cohort 3 or Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part A - Healthy Volunteers:&#xD;
&#xD;
          -  Written informed consent obtained prior to any required study-related procedure&#xD;
&#xD;
          -  Healthy female or male subject aged 18 to 65&#xD;
&#xD;
          -  Willing to use medically effective methods of birth control&#xD;
&#xD;
          -  Females of reproductive potential must have a negative serum pregnancy test at&#xD;
             screening and negative serum or urine pregnancy test prior to first study drug&#xD;
             application on Day 1&#xD;
&#xD;
          -  Non-smoker (no nicotine products for at least 6 months prior to screening)&#xD;
&#xD;
          -  BMI ≥18.5 kg/m2 and ≤32.0 kg/m2 with minimum weight of 60 kg&#xD;
&#xD;
        Part B- Subjects with AD:&#xD;
&#xD;
          -  Written informed consent obtained prior to any required study-related procedure&#xD;
&#xD;
          -  Confirmed diagnosis of active atopic dermatitis (AD)&#xD;
&#xD;
          -  History of AD for at least 6 months prior to Day 1 with an investigator global&#xD;
             assessment ≥3 and body surface area covered with 1-10% AD&#xD;
&#xD;
          -  Pruritus score (NRS)≥ 5 at screening and NRS ≥7 on Day 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Both Part A and Part B:&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Skin disease that may interfere with study assessments&#xD;
&#xD;
          -  Febrile illness within 6 days prior to Day 1, history of cancer within 5 years of Day&#xD;
             1, major surgery within 8 weeks prior to Day1, known immunodeficiencies, positive for&#xD;
             hepatitis B or C or HIV infection&#xD;
&#xD;
          -  Significant medical/surgical history or condition or current physical/laboratory/ECG/&#xD;
             vitals signs abnormality that might compromise the subject&#xD;
&#xD;
          -  Corrected QT duration ≥450 milliseconds or other significant ECG abnormality&#xD;
&#xD;
          -  Received marketed or investigational biological agent within 12 weeks prior to Day 1&#xD;
             or JAK inhibitor or nonbiological product or device within 4 weeks of Day 1 or within&#xD;
             8 weeks of Day 1 if investigational product used or any drug/ substance that is a&#xD;
             strong inhibitor or inducer of CYP3A4 or CYP2D6&#xD;
&#xD;
          -  Suspected hypersensitivity/allergy to lidocaine&#xD;
&#xD;
          -  Significant drug or alcohol abuse or mental illness in 2 years prior to Day 1&#xD;
&#xD;
        Part A Only- Healthy Volunteers:&#xD;
&#xD;
        -Used medications or skin emollients within 2 weeks prior to Day 1 unless approved by&#xD;
        investigator and sponsor&#xD;
&#xD;
        Part B Only - Subjects with AD:&#xD;
&#xD;
          -  Has infected atopic dermatitis&#xD;
&#xD;
          -  Used dupilumab 12 weeks prior to Day 1&#xD;
&#xD;
          -  Used doxepin, hydroxyzine or diphenhydramine, urea containing topical products within&#xD;
             1 week prior to Day 1&#xD;
&#xD;
          -  Used systemic antibiotics or topical medicated treatment or other systemic treatments&#xD;
             that could affect AD 2 weeks prior to Day 1&#xD;
&#xD;
          -  Received any UV-B phototherapy, excimer laser treatment or psoralen-UV-A treatment&#xD;
             within 4 weeks prior to Day 1&#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>Niranjan Rao, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Asana BioSciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Certified Research Associates</name>
      <address>
        <city>Cortland</city>
        <state>New York</state>
        <zip>13045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Consulting Services, PLLC</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaulding Research Clinic, Inc</name>
      <address>
        <city>West Bend</city>
        <state>Wisconsin</state>
        <zip>53095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovaderm Recherches Inc</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2K4L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</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>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Pruritus</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/NCT03798561
org study id: ASN008-101
nct id: NCT03798561
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an ascending dose escalation study to test the safety, tolerability and preliminary
      efficacy of ASN008 TG in first-in-human subjects
This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and
      tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in
      cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be
      determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate
      dermatitis. Results from Part A and B will characterize safety, tolerability and
      pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a
      numerical rating scale (NRS) of pruritus at baseline and on Day 15.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded
measure: Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B)
time frame: Part A: 14 days; Part B: 22 days
description: Analyze incidence of treatment-emergent adverse events (TEAE)
measure: Calculate area under the plasma concentration versus time curve (Part A and B)
time frame: 7 days and 16 days
description: A plot of the concentration of ASN008 in plasma over time
measure: Calculate the Pharmacokinetic Half-life (Part A and B)
time frame: 7 days and 16 days
description: Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%
measure: Calculate the Pharmacokinetic maximum concentration (Part A and B)
time frame: 7 days and 16 days
description: Maximum concentration of ASN008 achieved after dosing
measure: Change from baseline in pruritus NRS in AD subjects (Part B)
time frame: 22 days
description: Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution
measure: Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)
time frame: 22 days
description: Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe
measure: Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)
time frame: 22 Days
description: 5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema)
arm group label: 82 µg/cm2 ASN008 TG or Placebo
arm group type: Experimental
description: PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2)
arm group label: 164 µg/cm2 ASN008 TG or Placebo
arm group type: Experimental
description: PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2)
arm group label: 328 µg/cm2 ASN008 TG or Placebo
arm group type: Experimental
description: Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2)
arm group label: 492 µg/cm2 ASN008 TG or Placebo
arm group type: Experimental
description: Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)
arm group label: ASN008 TG TBD Cohort 1 or Placebo
arm group type: Experimental
description: Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3)
arm group label: ASN008 TG TBD Cohort 2 or Placebo
arm group type: Experimental
description: Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3)
arm group label: ASN008 TG TBD Cohort 3 or Placebo
arm group type: Experimental
description: Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)
intervention type: Drug
intervention name: ASN008 TG
description: ASN008 TG
arm group label: 164 µg/cm2 ASN008 TG or Placebo
arm group label: 328 µg/cm2 ASN008 TG or Placebo
arm group label: 492 µg/cm2 ASN008 TG or Placebo
arm group label: 82 µg/cm2 ASN008 TG or Placebo
arm group label: ASN008 TG TBD Cohort 1 or Placebo
arm group label: ASN008 TG TBD Cohort 2 or Placebo
arm group label: ASN008 TG TBD Cohort 3 or Placebo
intervention type: Drug
intervention name: Placebo TG
description: Placebo TG
arm group label: 164 µg/cm2 ASN008 TG or Placebo
arm group label: 328 µg/cm2 ASN008 TG or Placebo
arm group label: 492 µg/cm2 ASN008 TG or Placebo
arm group label: 82 µg/cm2 ASN008 TG or Placebo
arm group label: ASN008 TG TBD Cohort 1 or Placebo
arm group label: ASN008 TG TBD Cohort 2 or Placebo
arm group label: ASN008 TG TBD Cohort 3 or Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Niranjan Rao, PhD
role: Study Director
affiliation: Asana BioSciences
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Pruritus
sharing ipd: No