<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/NCT03748758</url>
  </required_header>
  <id_info>
    <org_study_id>OP0201-C-002</org_study_id>
    <nct_id>NCT03748758</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers</brief_title>
  <official_title>Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of two dose levels of&#xD;
      OP0201 and placebo, when administered intranasally in healthy adults subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With of Adverse Events</measure>
    <time_frame>21 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Adult Volunteers</condition>
  <arm_group>
    <arm_group_label>Drug: OP0201 (30 mg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort A- 30 mg per day X 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: OP0201 (60 mg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort B-60 mg per day X 14 days</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 (30 mg)</arm_group_label>
    <arm_group_label>Drug: OP0201 (60 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Drug: Placebo</intervention_name>
    <description>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 of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at&#xD;
             Screening.&#xD;
&#xD;
          2. Able and willing to follow study instructions (including compliance with daily study&#xD;
             treatment administration) and likely to complete all required study visits as assessed&#xD;
             by the Investigator's judgement.&#xD;
&#xD;
          3. Female subjects must agree to use an acceptable method of contraception (for pregnancy&#xD;
             considerations and contraceptive requirements).&#xD;
&#xD;
          4. Female subjects who are of childbearing potential must have a negative urine pregnancy&#xD;
             test result at Screening and Day -1 prior to randomization.&#xD;
&#xD;
          5. Male subjects must agree to use contraception&#xD;
&#xD;
          6. Subjects must agree to refrain from immersing their head fully under water (eg,&#xD;
             swimming, diving) from the time of signed informed consent until after the study exit&#xD;
             visit.&#xD;
&#xD;
          7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.&#xD;
&#xD;
        Exclusion Criteria includes but is not limited to:&#xD;
&#xD;
          1. History or presence of significant medical condition or a clinically significant&#xD;
             abnormal finding, as determined by the Investigator.&#xD;
&#xD;
          2. Presence of a clinically significant abnormal olfactory test finding at Screening&#xD;
             defined as a total UPSIT score &lt;35 (for females) and &lt;34 (for males).&#xD;
&#xD;
          3. Clinically significant ear disorder/disease currently or within 6 weeks prior to&#xD;
             Screening.&#xD;
&#xD;
          4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.&#xD;
&#xD;
          5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to&#xD;
             Screening.&#xD;
&#xD;
          6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently&#xD;
             or within 6 weeks prior to Screening.&#xD;
&#xD;
          7. Clinically relevant blockage of one or both nasal passages, in the Investigator's&#xD;
             opinion.&#xD;
&#xD;
          8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.&#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>Vince and Associates</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://novustherapeutics.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <results_first_submitted>January 30, 2020</results_first_submitted>
  <results_first_submitted_qc>February 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2020</results_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>October 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03748758/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>April 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03748758/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Drug: OP0201 Cohort A 30 mg Per Day</title>
          <description>Cohort A- 30 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
        </group>
        <group group_id="P2">
          <title>Drug: OP0201 Cohort B 60 mg Per Day</title>
          <description>Cohort B-60 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
        </group>
        <group group_id="P3">
          <title>Drug: Placebo</title>
          <description>0 mg per day X 14 days&#xD;
Drug: Placebo: Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Drug: OP0201 Cohort A 30 mg Per Day</title>
          <description>Cohort A- 30 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
        </group>
        <group group_id="B2">
          <title>Drug: OP0201 Cohort B 60 mg Per Day</title>
          <description>Cohort B-60 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
        </group>
        <group group_id="B3">
          <title>Drug: Placebo</title>
          <description>0 mg per day X 14 days&#xD;
Drug: Placebo: Placebo</description>
        </group>
        <group group_id="B4">
          <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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="30"/>
          </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="33.9" spread="7.2"/>
                    <measurement group_id="B2" value="32.2" spread="6.2"/>
                    <measurement group_id="B3" value="35.3" spread="10.4"/>
                    <measurement group_id="B4" value="33.5" spread="7.4"/>
                  </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="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="18"/>
                  </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 group_id="B4" 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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="14"/>
                  </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 group_id="B4" 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 group_id="B4" 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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With of Adverse Events</title>
        <time_frame>21 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 Cohort A 30 mg Per Day</title>
            <description>Cohort A- 30 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O2">
            <title>Drug: OP0201 Cohort B 60 mg Per Day</title>
            <description>Cohort B-60 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O3">
            <title>Drug: Placebo</title>
            <description>0 mg per day X 14 days&#xD;
Drug: Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With of Adverse Events</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint</title>
        <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 1 Baseline</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O2">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O3">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O4">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O5">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O6">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O7">
            <title>Drug: Placebo/ Day 1 Baseline</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O8">
            <title>Drug: Placebo/ Day 14: 30 Mins Predose</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O9">
            <title>Drug: Placebo/ Day 14: 5 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O10">
            <title>Drug: Placebo/ Day 14: 20 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O11">
            <title>Drug: Placebo/ Day 14: 35 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O12">
            <title>Drug: Placebo/ Day 14: 50 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint</title>
          <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
          <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="2"/>
                <count group_id="O12" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.05" spread="2.585"/>
                    <measurement group_id="O2" value="10.18" spread="2.703"/>
                    <measurement group_id="O3" value="10.35" spread="2.832"/>
                    <measurement group_id="O4" value="9.954" spread="2.475"/>
                    <measurement group_id="O5" value="9.813" spread="2.368"/>
                    <measurement group_id="O6" value="10.04" spread="2.564"/>
                    <measurement group_id="O7" value="9.525" spread="2.652"/>
                    <measurement group_id="O8" value="12.86" spread="6.145"/>
                    <measurement group_id="O9" value="14.03" spread="7.319"/>
                    <measurement group_id="O10" value="13.20" spread="6.505"/>
                    <measurement group_id="O11" value="12.80" spread="6.930"/>
                    <measurement group_id="O12" value="13.39" spread="6.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint</title>
        <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 1 Baseline</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O2">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O3">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O4">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O5">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O6">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O7">
            <title>Drug: Placebo/ Day 1 Baseline</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O8">
            <title>Drug: Placebo/ Day 14: 30 Mins Predose</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O9">
            <title>Drug: Placebo/ Day 14: 5 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O10">
            <title>Drug: Placebo/ Day 14: 20 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O11">
            <title>Drug: Placebo/ Day 14: 35 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O12">
            <title>Drug: Placebo/ Day 14: 50 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint</title>
          <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
          <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
          <units>µM</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="2"/>
                <count group_id="O12" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299.503" spread="61.999"/>
                    <measurement group_id="O2" value="290.103" spread="35.978"/>
                    <measurement group_id="O3" value="293.473" spread="56.417"/>
                    <measurement group_id="O4" value="279.852" spread="44.170"/>
                    <measurement group_id="O5" value="279.289" spread="44.424"/>
                    <measurement group_id="O6" value="276.788" spread="45.493"/>
                    <measurement group_id="O7" value="298.519" spread="126.157"/>
                    <measurement group_id="O8" value="363.530" spread="178.783"/>
                    <measurement group_id="O9" value="387.945" spread="200.583"/>
                    <measurement group_id="O10" value="363.476" spread="165.774"/>
                    <measurement group_id="O11" value="366.353" spread="195.732"/>
                    <measurement group_id="O12" value="368.159" spread="178.270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint</title>
        <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O2">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O3">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O4">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O5">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O6">
            <title>Drug: Placebo/ Day 14: 30 Mins Predose</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O7">
            <title>Drug: Placebo/ Day 14: 5 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O8">
            <title>Drug: Placebo/ Day 14: 20 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O9">
            <title>Drug: Placebo/ Day 14: 35 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O10">
            <title>Drug: Placebo/ Day 14: 50 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint</title>
          <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
          <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.309" spread="0.347"/>
                    <measurement group_id="O2" value="0.871" spread="0.787"/>
                    <measurement group_id="O3" value="0.383" spread="0.453"/>
                    <measurement group_id="O4" value="0.300" spread="0.407"/>
                    <measurement group_id="O5" value="0.447" spread="0.446"/>
                    <measurement group_id="O6" value="3.333" spread="3.490"/>
                    <measurement group_id="O7" value="4.505" spread="4.660"/>
                    <measurement group_id="O8" value="3.678" spread="3.850"/>
                    <measurement group_id="O9" value="3.278" spread="4.274"/>
                    <measurement group_id="O10" value="3.865" spread="4.009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint</title>
        <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O2">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O3">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O4">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O5">
            <title>Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins</title>
            <description>Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201</description>
          </group>
          <group group_id="O6">
            <title>Drug: Placebo/ Day 14: 30 Mins Predose</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O7">
            <title>Drug: Placebo/ Day 14: 5 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O8">
            <title>Drug: Placebo/ Day 14: 20 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O9">
            <title>Drug: Placebo/ Day 14: 35 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
          <group group_id="O10">
            <title>Drug: Placebo/ Day 14: 50 Mins</title>
            <description>0 mg per day X 14 days Drug: Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint</title>
          <description>This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day</description>
          <population>It is pre-specified to collect and report data for only &quot;Cohort B&quot; and &quot;Placebo&quot; Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.</population>
          <units>µM</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.341" spread="15.478"/>
                    <measurement group_id="O2" value="15.625" spread="18.781"/>
                    <measurement group_id="O3" value="6.697" spread="14.869"/>
                    <measurement group_id="O4" value="6.818" spread="13.839"/>
                    <measurement group_id="O5" value="5.699" spread="10.410"/>
                    <measurement group_id="O6" value="65.011" spread="52.626"/>
                    <measurement group_id="O7" value="89.426" spread="74.425"/>
                    <measurement group_id="O8" value="64.957" spread="39.617"/>
                    <measurement group_id="O9" value="67.834" spread="69.575"/>
                    <measurement group_id="O10" value="69.641" spread="52.113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>End of study (Day 21)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Drug: OP0201 Cohort A 30 mg Per Day</title>
          <description>Cohort A- 30 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
        </group>
        <group group_id="E2">
          <title>Drug: OP0201 Cohort B 60 mg Per Day</title>
          <description>Cohort B-60 mg per day X 14 days&#xD;
Drug: OP0201: Drug OP0201</description>
        </group>
        <group group_id="E3">
          <title>Drug: Placebo</title>
          <description>0 mg per day X 14 days&#xD;
Drug: Placebo: 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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Olfactory test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </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="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
              </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>No information, data or results shall be used by the Institution, Investigator or any other individual or entity other than the Sponsor. The use of Study Results by any party other than Sponsor requires prior written approval by the Sponsor.</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>study002@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/NCT03748758
org study id: OP0201-C-002
nct id: NCT03748758
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and tolerability of two dose levels of
      OP0201 and placebo, when administered intranasally in healthy adults subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With of Adverse Events
time frame: 21 Days
measure: Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint
time frame: Day 1 and Day 14
description: This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
measure: Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint
time frame: Day 1 and Day 14
description: This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
measure: Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint
time frame: Day 1 and Day 14
description: This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
measure: Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint
time frame: Day 1 and Day 14
description: This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
arm group label: Drug: OP0201 (30 mg)
arm group type: Active Comparator
description: Cohort A- 30 mg per day X 14 days
arm group label: Drug: Placebo
arm group type: Placebo Comparator
description: Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days
arm group label: Drug: OP0201 (60 mg)
arm group type: Active Comparator
description: Cohort B-60 mg per day X 14 days
intervention type: Combination Product
intervention name: Drug: OP0201
description: Drug OP0201
arm group label: Drug: OP0201 (30 mg)
arm group label: Drug: OP0201 (60 mg)
intervention type: Combination Product
intervention name: Drug: Placebo
description: Placebo
arm group label: Drug: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://novustherapeutics.com/
description: Related Info
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 