<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/NCT04494815</url>
  </required_header>
  <id_info>
    <org_study_id>SR419-102</org_study_id>
    <nct_id>NCT04494815</nct_id>
  </id_info>
  <brief_title>A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419</brief_title>
  <official_title>A Phase 1b, Randomised, Double-blind, Placebo- and Active Controlled, Single Dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients With Peripheral Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SIMR (Australia) Biotech Pty Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai SIMR Biotechnology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419&#xD;
      in Patients with Peripheral Neuropathic Pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, three-period, complete crossover, double-blind, randomised, placebo-&#xD;
      and active-controlled study to compare the preliminary efficacy of a single dose of SR419 to&#xD;
      placebo and active control in patients with peripheral neuropathic pain. The study also aims&#xD;
      to evaluate the safety, tolerability, and PK of single doses of SR419 in patients with&#xD;
      peripheral neuropathic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QST of an affected area.</measure>
    <time_frame>Up to Day18(-2~+5) for the safety follow up since Day1</time_frame>
    <description>QST: Quantitative sensory testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence, frequency, and severity of TEAEs.</measure>
    <time_frame>Up to Day18(-2~+5) for the safety follow up since Day1</time_frame>
    <description>TEAE: Treatment-Emergent Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous pain score</measure>
    <time_frame>Up to Day18(-2~+5) for the safety follow up since Day1</time_frame>
    <description>Pain score will be assessed via painDETECT questionnaire with a value range of 0~38, which includes three situations: If a subject gets a score of 0~12, it means a neuropathic pain component is unlikely(less than 15% probability); if a score of 13~19, it means the result is ambiguous, however, a neuropathic pain component can be present; if the score is equal to or greater than nineteen, it means a neuropathic pain is likely(more than 90% probability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QST of an unaffected area.</measure>
    <time_frame>Up to Day18(-2~+5) for the safety follow up since Day1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of SR419 after dosing.</measure>
    <time_frame>Up to Day11(+3)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Peripheral Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SR419</intervention_name>
    <description>Each participant will receive 1 dose of 20 mg SR419 oral suspension.</description>
    <arm_group_label>Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>active control</intervention_name>
    <description>Each participant will receive 1 dose of 300 mg active control capsule.</description>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SR419 placebo</intervention_name>
    <description>Each participant will receive 2 doses of SR419 placebo oral suspension.</description>
    <arm_group_label>Treatment B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>active control placebo</intervention_name>
    <description>Each participant will receive 2 doses of active control placebo capsule.</description>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥18 years at the time of informed consent.&#xD;
&#xD;
          2. Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically&#xD;
             PHN or DPN.&#xD;
&#xD;
          3. Average daily pain over the last week prior to Screening to be of at least moderate&#xD;
             severity (a score of ≥4 on the 11-point numeric rating scale [NRS]) and be of face,&#xD;
             limb or torso location.&#xD;
&#xD;
          4. A minimum score of 19 on the pain DETECT questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Being pregnant or lactating at Screening or planning to become pregnant (self or&#xD;
             partner) at any time during the study.&#xD;
&#xD;
          2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory&#xD;
             abnormality.&#xD;
&#xD;
          3. Known or suspected intolerance or hypersensitivity to any of the study drugs, close&#xD;
             related compounds, or any of the stated ingredients.&#xD;
&#xD;
          4. Participants on controlled-release opioids (e.g., morphine) unless on a stable dose of&#xD;
             Morphine Equivalent Dose (assessed by the Faculty of Pain Medicine Opioids Calculator)&#xD;
             of up to and including 60 mg/day, at the discretion of the Investigator. Participants&#xD;
             on instant-release opioids (e.g., codeine, oxycodone) must withhold dosing for 12&#xD;
             hours prior to administration of study drug.&#xD;
&#xD;
          5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
             (HBsAg), or hepatitis C virus (HCV).&#xD;
&#xD;
          6. Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) &lt;60&#xD;
             mL/min.&#xD;
&#xD;
          7. A history of major psychiatric disorder(s).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kai Wu</last_name>
    <role>Study Director</role>
    <affiliation>SIMR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Facility Medical School, University of Adelaide</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DPN, PHN...etc.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04494815
org study id: SR419-102
nct id: NCT04494815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
      in Patients with Peripheral Neuropathic Pain
This is a single center, three-period, complete crossover, double-blind, randomised, placebo-
      and active-controlled study to compare the preliminary efficacy of a single dose of SR419 to
      placebo and active control in patients with peripheral neuropathic pain. The study also aims
      to evaluate the safety, tolerability, and PK of single doses of SR419 in patients with
      peripheral neuropathic pain.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: QST of an affected area.
time frame: Up to Day18(-2~+5) for the safety follow up since Day1
description: QST: Quantitative sensory testing
measure: The incidence, frequency, and severity of TEAEs.
time frame: Up to Day18(-2~+5) for the safety follow up since Day1
description: TEAE: Treatment-Emergent Adverse Events
measure: Spontaneous pain score
time frame: Up to Day18(-2~+5) for the safety follow up since Day1
description: Pain score will be assessed via painDETECT questionnaire with a value range of 0~38, which includes three situations: If a subject gets a score of 0~12, it means a neuropathic pain component is unlikely(less than 15% probability); if a score of 13~19, it means the result is ambiguous, however, a neuropathic pain component can be present; if the score is equal to or greater than nineteen, it means a neuropathic pain is likely(more than 90% probability).
measure: QST of an unaffected area.
time frame: Up to Day18(-2~+5) for the safety follow up since Day1
measure: Plasma concentration of SR419 after dosing.
time frame: Up to Day11(+3)
arm group label: Treatment A
arm group type: Experimental
description: Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
arm group label: Treatment B
arm group type: Active Comparator
description: Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
arm group label: Treatment C
arm group type: Placebo Comparator
description: Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
intervention type: Drug
intervention name: SR419
description: Each participant will receive 1 dose of 20 mg SR419 oral suspension.
arm group label: Treatment A
intervention type: Drug
intervention name: active control
description: Each participant will receive 1 dose of 300 mg active control capsule.
arm group label: Treatment B
arm group label: Treatment C
intervention type: Drug
intervention name: SR419 placebo
description: Each participant will receive 2 doses of SR419 placebo oral suspension.
arm group label: Treatment B
intervention type: Drug
intervention name: active control placebo
description: Each participant will receive 2 doses of active control placebo capsule.
arm group label: Treatment A
arm group label: Treatment C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kai Wu
role: Study Director
affiliation: SIMR
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Neuralgia