<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/NCT03828149</url>
  </required_header>
  <id_info>
    <org_study_id>OP0201-C-001</org_study_id>
    <nct_id>NCT03828149</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults</brief_title>
  <official_title>Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novus Therapeutics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novus Therapeutics, Inc</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">March 7, 2019</completion_date>
  <primary_completion_date type="Actual">March 7, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety (Evaluation of Adverse Events)</measure>
    <time_frame>Days 1-9</time_frame>
    <description>All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy Adults</condition>
  <arm_group>
    <arm_group_label>Drug: OP0201</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Drug:OP0201</intervention_name>
    <description>Drug: OP0201</description>
    <arm_group_label>Drug: OP0201</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Drug: Placebo</intervention_name>
    <description>Drug: Placebo</description>
    <arm_group_label>Drug: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria includes but is not limited to:&#xD;
&#xD;
          1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.&#xD;
&#xD;
          2. No history or presence of significant medical condition or a clinically significant&#xD;
             abnormal finding, as determined by the investigator.&#xD;
&#xD;
          3. Negative urine pregnancy test at screening and baseline for females of childbearing&#xD;
             potential&#xD;
&#xD;
          4. Agree to refrain from water immersion of the ears from the time of signed informed&#xD;
             consent to the end of trial&#xD;
&#xD;
          5. Physiologic tympanogram type A (normal) or type C at screening visit&#xD;
&#xD;
        Exclusion Criteria includes but is not limited to:&#xD;
&#xD;
          1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to&#xD;
             screening visit&#xD;
&#xD;
          2. Positive urine drug screen at screening visit&#xD;
&#xD;
          3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit&#xD;
&#xD;
          4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation)&#xD;
             currently or within 6 weeks prior to screening visit&#xD;
&#xD;
          5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a&#xD;
             hypobaric/hyperbaric atmospheric pressure chamber&#xD;
&#xD;
          6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit&#xD;
&#xD;
          7. Clinically significant findings on ear nose and throat exam&#xD;
&#xD;
          8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit&#xD;
&#xD;
          9. Current diagnosis of sleep apnea&#xD;
&#xD;
         10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may&#xD;
             interfere with ET function&#xD;
&#xD;
         11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg,&#xD;
             cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cologne University Hospital</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://novustherapeutics.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>October 30, 2019</results_first_submitted>
  <results_first_submitted_qc>December 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 30, 2019</results_first_posted>
  <last_update_submitted>December 6, 2019</last_update_submitted>
  <last_update_submitted_qc>December 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03828149/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03828149/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Drug: OP0201 First, Then Placebo</title>
          <description>Participants first received 20mg one time dose of OP0201, followed by a washout and then a single dose of Placebo, cross over design&#xD;
Drug:OP0201: Drug: OP0201</description>
        </group>
        <group group_id="P2">
          <title>Drug: Placebo First, Then OP0201</title>
          <description>Participants first received 0 mg one time dose of Placebo, followed by a washout and then a single dose of OP0201, cross over design&#xD;
Drug: Placebo: Drug: Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (Single Dose)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (6 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (Single Dose)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Drug: OP0201 First, Then Placebo</title>
          <description>Participants first received 20mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design&#xD;
Drug:OP0201: Drug: OP0201</description>
        </group>
        <group group_id="B2">
          <title>Drug: Placebo First, Then OP0201</title>
          <description>Participants first received 0 mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design&#xD;
Drug: Placebo: Drug: Placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.0" spread="5.7"/>
                    <measurement group_id="B2" value="24.5" spread="3.9"/>
                    <measurement group_id="B3" value="25.8" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety (Evaluation of Adverse Events)</title>
        <description>All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.</description>
        <time_frame>Days 1-9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201</title>
            <description>Participants received 20mg OP0201 one time dose at Day 1 or Day 8.&#xD;
Drug:OP0201: Drug: OP0201</description>
          </group>
          <group group_id="O2">
            <title>Drug: Placebo</title>
            <description>Participants received 0 mg one time dose at Day 1 or Day 8.&#xD;
Drug: Placebo: Drug: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Safety (Evaluation of Adverse Events)</title>
          <description>All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 days</time_frame>
      <desc>The safety population included all randomized participants who received at least one spray of study treatment in either nare.</desc>
      <group_list>
        <group group_id="E1">
          <title>OP0201</title>
          <description>Participants received OP0201 20mg one time dose at either Day 1 or Day 8.&#xD;
Drug:OP0201: Drug: OP0201</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received Placebo 0 mg one time dose at either Day 1 or Day 8.&#xD;
Drug: Placebo: Drug: Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tympanic membrane hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tympanic membrane disorder</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nasal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Director</name_or_title>
      <organization>Novus Therapeutics</organization>
      <phone>949-679-1110</phone>
      <email>study001@novustherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03828149
org study id: OP0201-C-001
nct id: NCT03828149
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Safety (Evaluation of Adverse Events)
time frame: Days 1-9
description: All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.
arm group label: Drug: OP0201
arm group type: Active Comparator
description: 20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design
arm group label: Drug: Placebo
arm group type: Placebo Comparator
description: 0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design
intervention type: Combination Product
intervention name: Drug:OP0201
description: Drug: OP0201
arm group label: Drug: OP0201
intervention type: Combination Product
intervention name: Drug: Placebo
description: Drug: Placebo
arm group label: Drug: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: http://novustherapeutics.com/
description: Related Info
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 