<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/NCT04502901</url>
  </required_header>
  <id_info>
    <org_study_id>KX0826-US-1002</org_study_id>
    <nct_id>NCT04502901</nct_id>
  </id_info>
  <brief_title>the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Male Subjects With Androgenetic Alopecia to Evaluate the Safety, Tolerability and PK of KX-826 Following Topical Multiple Dose Ascending</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Kintor Pharmaceutical Inc,</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suzhou Kintor Pharmaceutical Inc,</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized, double-blind, placebo-controlled, dose-escalation study to&#xD;
      evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose&#xD;
      administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      KX-826 topical solution will be applied to the scalp of healthy male subjects with&#xD;
      androgenetic alopecia.&#xD;
&#xD;
      A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug&#xD;
      and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each&#xD;
      dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to&#xD;
      receive placebo for a total of 4 dose cohorts).&#xD;
&#xD;
      Cohort Dose of KX-826 Subjects&#xD;
&#xD;
        1. 2.5 mg QD for 14 days 10 (8 active + 2 placebo)&#xD;
&#xD;
        2. 5 mg QD for 14 days 10 (8 active + 2 placebo)&#xD;
&#xD;
        3. 10 mg QD for 14 days 10 (8 active + 2 placebo)&#xD;
&#xD;
        4. 20 mg QD for 14 days 10 (8 active + 2 placebo)&#xD;
&#xD;
      Dose escalation will not occur until review of the multiple dose safety from the previous&#xD;
      dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs&#xD;
      (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory&#xD;
      findings, 12-lead ECGs, skin irritation assessments and physical examination findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 11, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments</measure>
    <time_frame>19 days</time_frame>
    <description>skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of study drug related TEAEs</measure>
    <time_frame>19 days</time_frame>
    <description>incidence of study drug related TEAEs (possibly, probably or definitely)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax)</measure>
    <time_frame>1 day</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at which Cmax was first observed (Tmax)</measure>
    <time_frame>1 day</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)</measure>
    <time_frame>1 day</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve for on dosing interval at steady state (AUC0-t)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax at steady state (Cmax_ss)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at which Cmax_ss was first observed (Tmax_ss)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum observed or &quot;trough&quot; concentration at steady state (Cmin_ss)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average concentration at steady state (Cav_ss)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC from time 0 and extrapolated to infinite time, total exposure (AUCinf)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC from time 0 to the last non-zero concentration (AUClast)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological half-life (T1/2 el)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant (Kel)</measure>
    <time_frame>19 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Androgenetic Alopecia</condition>
  <arm_group>
    <arm_group_label>Experimental Group -KX0826</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KX0826 is tropically applied to the scalp of healthy male subjects once a day for 14 days. The applied dosage cohorts are 2.5mg, 5mg, 10mg and 20mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group- Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is tropically applied to the scalp of healthy male subjects once a day for 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KX0826</intervention_name>
    <description>investigational AR antagonist</description>
    <arm_group_label>Experimental Group -KX0826</arm_group_label>
    <other_name>Pyrilutamide</other_name>
    <other_name>KX-826</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo of KX-826</description>
    <arm_group_label>Control Group- Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are capable of giving informed consent and complying with study procedures;&#xD;
&#xD;
          2. Are males between the ages of 18 and 60 years, inclusive;&#xD;
&#xD;
          3. Have a clinical diagnosis of androgenetic alopecia;&#xD;
&#xD;
          4. Considered healthy by the Principal Investigator, based on a detailed medical history,&#xD;
             full physical examination, clinical laboratory tests, 12-lead ECG and vital signs&#xD;
             (systolic blood pressure ≥90 and ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg&#xD;
             and pulse rate ≥45 and ≤100 bpm; one repeat allowed to confirm out of range values);&#xD;
&#xD;
          5. Have normal renal and hepatic function as determined by the screening laboratory&#xD;
             results;&#xD;
&#xD;
          6. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6&#xD;
             months before screening;&#xD;
&#xD;
          7. Body mass index (BMI) of 19.0 to 35.0 kg/m2 inclusive and body weight not less than 50&#xD;
             kg;&#xD;
&#xD;
          8. Willing and able to adhere to study restrictions and to be confined at the CRU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,&#xD;
             endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,&#xD;
             immunologic, lipid metabolism disorders, or drug hypersensitivity;&#xD;
&#xD;
          2. Any visible skin disease, damage or condition at the application site which, in the&#xD;
             opinion of the investigator, could compromise subject safety and/or interfere with the&#xD;
             evaluation of the test site reaction;&#xD;
&#xD;
          3. Subject has any dermatological disorders of the scalp;&#xD;
&#xD;
          4. Subject has a history of hair transplants, hair weaves;&#xD;
&#xD;
          5. Subject has hypersensitivity to previously prescribed minoxidil or finasteride;&#xD;
&#xD;
          6. Known or suspected malignancy;&#xD;
&#xD;
          7. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface&#xD;
             antigen (HBsAg), or hepatitis C virus (HCV) antibody;&#xD;
&#xD;
          8. A hospital admission or major surgery within 30 days prior to screening;&#xD;
&#xD;
          9. Participation in any other investigational drug trial within 30 days prior to&#xD;
             screening;&#xD;
&#xD;
         10. A history of prescription drug abuse, or illicit drug use within 6 months prior to&#xD;
             screening;&#xD;
&#xD;
         11. A history of alcohol abuse according to medical history within 6 months prior to&#xD;
             screening;&#xD;
&#xD;
         12. A positive screen for alcohol or drugs of abuse;&#xD;
&#xD;
         13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or&#xD;
             blood products) or acute loss of blood during the 90 days prior to screening;&#xD;
&#xD;
         14. Use of prescription or over-the-counter (OTC) medications, and herbal (including St&#xD;
             John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use&#xD;
             of acetaminophen at &lt;3g/day is permitted until 24 hours prior to dosing);&#xD;
&#xD;
         15. An unwillingness of male participants to use appropriate contraceptive measures if&#xD;
             engaging in sexual intercourse with a female partner of childbearing potential.&#xD;
             Appropriate measures include use of a condom and spermicide and, for female partners,&#xD;
             use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives,&#xD;
             injectable progesterone, progesterone subdermal implants, or a tubal ligation.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phoebe Zhang</last_name>
    <role>Study Director</role>
    <affiliation>Suzhou Kintor Pharmaceuticals Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>inVentiv Health Clinical Research Services LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</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>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</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/NCT04502901
org study id: KX0826-US-1002
nct id: NCT04502901
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The study is a randomized, double-blind, placebo-controlled, dose-escalation study to
      evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose
      administration.
KX-826 topical solution will be applied to the scalp of healthy male subjects with
      androgenetic alopecia.

      A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug
      and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each
      dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to
      receive placebo for a total of 4 dose cohorts).

      Cohort Dose of KX-826 Subjects

        1. 2.5 mg QD for 14 days 10 (8 active + 2 placebo)

        2. 5 mg QD for 14 days 10 (8 active + 2 placebo)

        3. 10 mg QD for 14 days 10 (8 active + 2 placebo)

        4. 20 mg QD for 14 days 10 (8 active + 2 placebo)

      Dose escalation will not occur until review of the multiple dose safety from the previous
      dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs
      (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory
      findings, 12-lead ECGs, skin irritation assessments and physical examination findings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
time frame: 19 days
description: skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
measure: Incidence of study drug related TEAEs
time frame: 19 days
description: incidence of study drug related TEAEs (possibly, probably or definitely)
measure: Maximum observed concentration (Cmax)
time frame: 1 day
description: Pharmacokinetics
measure: Time at which Cmax was first observed (Tmax)
time frame: 1 day
description: Pharmacokinetics
measure: Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
time frame: 1 day
description: Pharmacokinetics
measure: Area under the concentration curve for on dosing interval at steady state (AUC0-t)
time frame: 19 days
description: Pharmacokinetics
measure: Cmax at steady state (Cmax_ss)
time frame: 19 days
description: Pharmacokinetics
measure: Time at which Cmax_ss was first observed (Tmax_ss)
time frame: 19 days
description: Pharmacokinetics
measure: Minimum observed or "trough" concentration at steady state (Cmin_ss)
time frame: 19 days
description: Pharmacokinetics
measure: Average concentration at steady state (Cav_ss)
time frame: 19 days
description: Pharmacokinetics
measure: AUC from time 0 and extrapolated to infinite time, total exposure (AUCinf)
time frame: 19 days
description: Pharmacokinetics
measure: AUC from time 0 to the last non-zero concentration (AUClast)
time frame: 19 days
description: Pharmacokinetics
measure: Biological half-life (T1/2 el)
time frame: 19 days
description: Pharmacokinetics
measure: Terminal elimination rate constant (Kel)
time frame: 19 days
description: Pharmacokinetics
arm group label: Experimental Group -KX0826
arm group type: Experimental
description: KX0826 is tropically applied to the scalp of healthy male subjects once a day for 14 days. The applied dosage cohorts are 2.5mg, 5mg, 10mg and 20mg.
arm group label: Control Group- Placebo
arm group type: Placebo Comparator
description: Placebo is tropically applied to the scalp of healthy male subjects once a day for 14 days.
intervention type: Drug
intervention name: KX0826
description: investigational AR antagonist
arm group label: Experimental Group -KX0826
other name: Pyrilutamide
other name: KX-826
intervention type: Other
intervention name: Placebo
description: Placebo of KX-826
arm group label: Control Group- Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Phoebe Zhang
role: Study Director
affiliation: Suzhou Kintor Pharmaceuticals Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
sharing ipd: No