xml: <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/NCT06030414</url>
    </required_header>
    <id_info>
      <org_study_id>COV01</org_study_id>
      <nct_id>NCT06030414</nct_id>
    </id_info>
    <brief_title>A Study to Determine the Tolerability of Intranasal LMN-301</brief_title>
    <official_title>A Phase 1, Single-site, Open-label Study to Determine the Safety and Tolerability of Single and Multiple Doses of Intranasally Administered LMN-301 in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lumen Bioscience, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lumen Bioscience, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        LMN-301 is to prevent infection by SARS-CoV-2 (the virus causing Covid-19 disease) in&#xD;
        uninfected individuals. This study aims to assess whether the formulation will cause&#xD;
        irritation when administered in the nose, and how long its protective effects will last.&#xD;
  &#xD;
        Thirty five healthy adult volunteers will participate in this study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of adverse events as assessed by CTCAE v5.0 for 28 days after the first dose of LMN-301</measure>
      <time_frame>Daily for 28 days</time_frame>
      <description>All AEs will be coded using the latest version of MedDRA by system organ class (SOC) and preferred term, classified from verbatim terms. The number of treatment-emergent AEs (TEAEs) as well as the number and percentage of participants with at least one TEAE, will be summarized by SOC and preferred term. Summaries of TEAEs by severity as assessed by CTCAE v5.0 and relationship will also be presented. Summaries will also be presented for SAEs, TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings. Solicited and unsolicited TEAEs will be summarized separately.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants discontinuing from the study</measure>
      <time_frame>For 28 days after the first dose of LMN-301</time_frame>
      <description>The number of participants discontinuing from the study and the reason for discontinuation will be summarized.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from baseline vital sign measures (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate)</measure>
      <time_frame>In part A vital signs are measured on Days 1 (5 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (5 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.</time_frame>
      <description>Observed values and changes from baseline for vital signs (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate) will be summarized at each scheduled timepoint using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from baseline safety laboratory measures (hematology, clinical chemistry and coagulation)</measure>
      <time_frame>For Part A on Days 1, 2, 8 and 14 and For Part B on Days 1, 3 or 4, 7, 14 and 28</time_frame>
      <description>Clinical laboratory safety data will be summarized by laboratory measure (hematology, clinical chemistry and coagulation). Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from baseline ECG parameters (PR interval, QRS duration, QTcB, QTcF and ventricular heart rate)</measure>
      <time_frame>Screening and Day 14</time_frame>
      <description>The following ECG parameters will be analyzed: PR interval, QRS duration, QTcB, QTcF and ventricular heart rate. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.&#xD;
  For QTcF, the number of participants with values greater than 450 (and 480, 500) msec or an increase from baseline of at least 30 (and 60) msec will also be tabulated, in accordance with ICH E14</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from baseline nasal symptoms using the Sino-Nasal Outcome Test (total score)</measure>
      <time_frame>For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28</time_frame>
      <description>Scores will be totaled for all 22 symptoms. Changes from baseline in individual total SNOT-22 scores will be calculated as the post-baseline value minus the baseline value. Thus, a negative change will reflect an improvement in the corresponding score. Observed values and changes from baseline will be summarized at each scheduled timepoint by treatment using descriptive statistics and tabulated for each cohort (dose level) and overall.&#xD;
  Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT score will also be included in the listing.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Sentinel Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Main Cohort Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Main Cohort Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Main Cohort Group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>LMN-301</intervention_name>
      <description>Intranasally administered powder.</description>
      <arm_group_label>Main Cohort Group 1</arm_group_label>
      <arm_group_label>Main Cohort Group 2</arm_group_label>
      <arm_group_label>Main Cohort Group 3</arm_group_label>
      <arm_group_label>Sentinel Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Individuals must meet all the following criteria to be eligible to participate in this&#xD;
          study:&#xD;
  &#xD;
            1. Adult (between 18 and 65 years of age) at screening&#xD;
  &#xD;
            2. BMI ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening.&#xD;
  &#xD;
            3. General good health, without significant medical illness or abnormal physical&#xD;
               examination findings per investigator discretion.&#xD;
  &#xD;
            4. No clinically significant laboratory values at screening for haematology, serum&#xD;
               chemistry, coagulation, and urinalysis in the opinion of the Investigator. A repeat&#xD;
               test is allowed at the investigator's discretion.&#xD;
  &#xD;
            5. Normal electrocardiogram (ECG) with no QTcF prolongation.&#xD;
  &#xD;
            6. Must have provided written informed consent to participate in the clinical trial&#xD;
               before any study-related activities are carried out and, in the Investigator's&#xD;
               opinion, must be able to understand the full nature and purpose of the trial,&#xD;
               including possible risks and adverse effects.&#xD;
  &#xD;
            7. In the investigator's opinion, participant is willing and able to comply with all&#xD;
               study assessments and adhere to the protocol schedule and restrictions.&#xD;
  &#xD;
          Female volunteers:&#xD;
  &#xD;
            1. Must be of non-child-bearing potential, i.e., surgically sterilized (hysterectomy,&#xD;
               bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening&#xD;
               visit or postmenopausal (where postmenopausal is defined as no menses for 12 months&#xD;
               without an alternative medical cause (confirmed with FSH testing), or&#xD;
  &#xD;
            2. If of child-bearing potential, must have a negative serum pregnancy test at screening&#xD;
               and negative urine pregnancy test before the first study drug administration. They&#xD;
               must agree not to attempt to become pregnant, must not donate ova, and must agree to&#xD;
               use a highly effective method of contraception from signing consent, throughout the&#xD;
               study and for at least 30 days after the last dose of study drug. For contraception&#xD;
               guidelines see Appendix 4.&#xD;
  &#xD;
               9. Male volunteers must agree not to donate sperm and if engaging in sexual&#xD;
               intercourse with a female partner who could become pregnant, must agree to use a&#xD;
               condom in addition to having the female partner use a highly effective contraceptive&#xD;
               method (Appendix 4) from signing consent, during the study, and at least 90 days after&#xD;
               the last dose of study drug.&#xD;
  &#xD;
               Exclusion Criteria&#xD;
  &#xD;
               Individuals will be excluded from this study if they meet any of the following&#xD;
               criteria:&#xD;
  &#xD;
                 1. History or presence of clinically significant disease, including (but not limited&#xD;
                    to) clinically significant cardiovascular, pulmonary, hepatic, renal,&#xD;
                    hematological, gastrointestinal, endocrine, immunologic, dermatologic,&#xD;
                    neurological or psychiatric disease, including any acute illness or surgery&#xD;
                    within the past 3 months prior to screening determined by the PI to be clinically&#xD;
                    relevant.&#xD;
  &#xD;
                 2. Known allergy or previous anaphylaxis to any components of the investigational&#xD;
                    product&#xD;
  &#xD;
                 3. Allergies, history of allergic disease or chronic respiratory diseases including&#xD;
                    mild asthma. History of childhood asthma or childhood allergies are not&#xD;
                    exclusionary.&#xD;
  &#xD;
                 4. History of nasal or upper respiratory pathology or abnormalities&#xD;
  &#xD;
                 5. Ongoing, defined as within 30 days of dosing through end of follow-up, usage of&#xD;
                    nasal spray or nasal drops&#xD;
  &#xD;
                 6. Treatment with an experimental device or compound within 30 days of the first&#xD;
                    dose of study drug.&#xD;
  &#xD;
                 7. Treatment within 30 days of the first dose of the study medication or planned use&#xD;
                    within the study period with immunomodulator or immunosuppressant agent or&#xD;
                    medicines (over the counter [OTC], herbal, prescription, or supplement) with&#xD;
                    significant activity in the respiratory tract.&#xD;
  &#xD;
                 8. Pregnancy, anticipated pregnancy, or breastfeeding/lactating&#xD;
  &#xD;
                 9. Alcohol or drug abuse/dependency (defined as more than 10 standard drinks per&#xD;
                    week or more than 4 standard drinks on any one day, where 1 standard drink is 10&#xD;
                    g of pure alcohol) within 3 months prior to screening.&#xD;
  &#xD;
                10. Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at&#xD;
                    investigator discretion. Tobacco or nicotine consumption is not permitted from&#xD;
                    screening and until the end of follow-up.&#xD;
  &#xD;
                11. Positive alcohol breath test. Repeat test is allowed at investigator discretion.&#xD;
  &#xD;
                12. Individuals unable or unwilling to provide adequate informed consent&#xD;
  &#xD;
                13. COVID-19 positive&#xD;
  &#xD;
                14. Positive test results for active human immunodeficiency virus (HIV), hepatitis B&#xD;
                    surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Carl Mason, Dr.</last_name>
      <phone>206-899-1904</phone>
      <email>trials@lumen.bio</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Asa Davis, Dr.</last_name>
      <phone>206-899-1904</phone>
      <email>trials@lumen.bio</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030414
  org study id: COV01
  nct id: NCT06030414
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  LMN-301 is to prevent infection by SARS-CoV-2 (the virus causing Covid-19 disease) in
        uninfected individuals. This study aims to assess whether the formulation will cause
        irritation when administered in the nose, and how long its protective effects will last.
  
        Thirty five healthy adult volunteers will participate in this study.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Occurrence of adverse events as assessed by CTCAE v5.0 for 28 days after the first dose of LMN-301
  time frame: Daily for 28 days
  description: All AEs will be coded using the latest version of MedDRA by system organ class (SOC) and preferred term, classified from verbatim terms. The number of treatment-emergent AEs (TEAEs) as well as the number and percentage of participants with at least one TEAE, will be summarized by SOC and preferred term. Summaries of TEAEs by severity as assessed by CTCAE v5.0 and relationship will also be presented. Summaries will also be presented for SAEs, TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings. Solicited and unsolicited TEAEs will be summarized separately.
  measure: Number of participants discontinuing from the study
  time frame: For 28 days after the first dose of LMN-301
  description: The number of participants discontinuing from the study and the reason for discontinuation will be summarized.
  measure: Changes from baseline vital sign measures (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate)
  time frame: In part A vital signs are measured on Days 1 (5 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (5 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
  description: Observed values and changes from baseline for vital signs (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate) will be summarized at each scheduled timepoint using descriptive statistics.
  measure: Changes from baseline safety laboratory measures (hematology, clinical chemistry and coagulation)
  time frame: For Part A on Days 1, 2, 8 and 14 and For Part B on Days 1, 3 or 4, 7, 14 and 28
  description: Clinical laboratory safety data will be summarized by laboratory measure (hematology, clinical chemistry and coagulation). Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
  measure: Changes from baseline ECG parameters (PR interval, QRS duration, QTcB, QTcF and ventricular heart rate)
  time frame: Screening and Day 14
  description: The following ECG parameters will be analyzed: PR interval, QRS duration, QTcB, QTcF and ventricular heart rate. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.
  For QTcF, the number of participants with values greater than 450 (and 480, 500) msec or an increase from baseline of at least 30 (and 60) msec will also be tabulated, in accordance with ICH E14
  measure: Changes from baseline nasal symptoms using the Sino-Nasal Outcome Test (total score)
  time frame: For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28
  description: Scores will be totaled for all 22 symptoms. Changes from baseline in individual total SNOT-22 scores will be calculated as the post-baseline value minus the baseline value. Thus, a negative change will reflect an improvement in the corresponding score. Observed values and changes from baseline will be summarized at each scheduled timepoint by treatment using descriptive statistics and tabulated for each cohort (dose level) and overall.
  Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT score will also be included in the listing.
  arm group label: Sentinel Cohort
  arm group type: Experimental
  arm group label: Main Cohort Group 1
  arm group type: Experimental
  arm group label: Main Cohort Group 2
  arm group type: Experimental
  arm group label: Main Cohort Group 3
  arm group type: Experimental
  intervention type: Biological
  intervention name: LMN-301
  description: Intranasally administered powder.
  arm group label: Main Cohort Group 1
  arm group label: Main Cohort Group 2
  arm group label: Main Cohort Group 3
  arm group label: Sentinel Cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Carl Mason, Dr.
  phone: 206-899-1904
  email: trials@lumen.bio
  last name: Asa Davis, Dr.
  phone: 206-899-1904
  email: trials@lumen.bio
  responsible party type: Sponsor
  sharing ipd: No