<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/NCT03300687</url>
  </required_header>
  <id_info>
    <org_study_id>FX-322-103</org_study_id>
    <nct_id>NCT03300687</nct_id>
  </id_info>
  <brief_title>First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation</brief_title>
  <official_title>First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Frequency Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Frequency Therapeutics</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1 safety study performed in male or female adult participants with an&#xD;
      established diagnosis of severe to profound sensorineural hearing loss that meets the&#xD;
      criteria for cochlear implantation and the participant has already chosen to undergo cochlear&#xD;
      implant surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 12 participants will be enrolled in the study. Assessed will be safety and&#xD;
      tolerability of FX-322 administered by intratympanic injection. Also assessed will be the&#xD;
      FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of&#xD;
      FX-322 to determine the systemic exposure to FX-322.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2017</start_date>
  <completion_date type="Actual">January 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 12, 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.</measure>
    <time_frame>Treatment-emergent adverse events will be assessed over a several hour to two week period</time_frame>
    <description>To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Pharmacokinetics</measure>
    <time_frame>Systemic exposure will be evaluated over a 72 hour period</time_frame>
    <description>Drug exposure in the systemic circulation by evaluating Cmax and AUC Drug exposure evaluated by area under the plasma concentration versus time curve (AUC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Pharmacokinetics</measure>
    <time_frame>Within a 24 hour period after injection</time_frame>
    <description>Peak Plasma Concentration (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cochlear Perilymph Pharmacokinetics</measure>
    <time_frame>within a 24 hour period after injection</time_frame>
    <description>single time point measurement in each patient of drug in cochlear perilymph</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive FX-322 as an intratympanic injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive Placebo as an intratympanic injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FX-322</intervention_name>
    <description>intratympanic injection</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>intratympanic injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adult subjects with an established diagnosis of severe to profound&#xD;
             sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that&#xD;
             meets the criteria for cochlear implantation and the subject has already chosen to&#xD;
             undergo cochlear implant surgery.&#xD;
&#xD;
          2. Willingness and ability to comply with scheduled visits, ear examination, drug&#xD;
             administration plan, auditory and laboratory tests, study restrictions, and all study&#xD;
             procedures.&#xD;
&#xD;
        Other protocol-defined inclusion criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Persistent perforation of tympanic membrane or other tympanic membrane disorder that&#xD;
             would interfere with the delivery and safety assessment of an intra -tympanic&#xD;
             medication or reasonably be suspected to affect tympanic membrane healing after&#xD;
             injection.&#xD;
&#xD;
          2. Any conductive component defined as air-bone gaps &gt;10 dB at two or more frequencies.&#xD;
&#xD;
        Other protocol-defined exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Victoria Eye and Ear Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>April 11, 2018</last_update_submitted>
  <last_update_submitted_qc>April 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2018</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>Hearing Loss</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/NCT03300687
org study id: FX-322-103
nct id: NCT03300687
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a phase 1 safety study performed in male or female adult participants with an
      established diagnosis of severe to profound sensorineural hearing loss that meets the
      criteria for cochlear implantation and the participant has already chosen to undergo cochlear
      implant surgery.
Approximately 12 participants will be enrolled in the study. Assessed will be safety and
      tolerability of FX-322 administered by intratympanic injection. Also assessed will be the
      FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of
      FX-322 to determine the systemic exposure to FX-322.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Participant)
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.
time frame: Treatment-emergent adverse events will be assessed over a several hour to two week period
description: To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.
measure: Plasma Pharmacokinetics
time frame: Systemic exposure will be evaluated over a 72 hour period
description: Drug exposure in the systemic circulation by evaluating Cmax and AUC Drug exposure evaluated by area under the plasma concentration versus time curve (AUC)
measure: Plasma Pharmacokinetics
time frame: Within a 24 hour period after injection
description: Peak Plasma Concentration (Cmax)
measure: Cochlear Perilymph Pharmacokinetics
time frame: within a 24 hour period after injection
description: single time point measurement in each patient of drug in cochlear perilymph
arm group label: Active
arm group type: Active Comparator
description: Subjects will receive FX-322 as an intratympanic injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive Placebo as an intratympanic injection
intervention type: Drug
intervention name: FX-322
description: intratympanic injection
arm group label: Active
intervention type: Drug
intervention name: Placebo
description: intratympanic injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Hearing Loss