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Completed

NCT Number: NCT06030414

A Study to Determine the Tolerability of Intranasal LMN-301

LMN-301 is to prevent infection by severe acute respiratory syndrome-corona virus (SARS-CoV-2) (the virus causing coronavirus disease of 2019 (COVID-19) 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Individuals must meet all the following criteria to be eligible to participate in this study:

  • Adult (between 18 and 65 years of age) at screening
  • BMI ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening.
  • General good health, without significant medical illness or abnormal physical examination findings per investigator discretion.
  • No clinically significant laboratory values at screening for haematology, serum chemistry, coagulation, and urinalysis in the opinion of the Investigator. A repeat test is allowed at the investigator's discretion.
  • Normal electrocardiogram (ECG) with no QTcF prolongation.
  • Must have provided written informed consent to participate in the clinical trial before any study-related activities are carried out and, in the Investigator's opinion, must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • In the investigator's opinion, participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Female volunteers:

  • Must be of non-child-bearing potential, i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause (confirmed with follicle stimulating hormone (FSH) testing), or
  • If of child-bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test before the first study drug administration. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use a highly effective method of contraception from signing consent, throughout the study and for at least 30 days after the last dose of study drug. For contraception guidelines see Appendix 4.
  • Male volunteers must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 4) from signing consent, during the study, and at least 90 days after the last dose of study drug.

Exclusion criteria

Individuals will be excluded from this study if they meet any of the following criteria:

  • History or presence of clinically significant disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease, including any acute illness or surgery within the past 3 months prior to screening determined by the PI to be clinically relevant.
  • Known allergy or previous anaphylaxis to any components of the investigational product
  • Allergies, history of allergic disease or chronic respiratory diseases including mild asthma. History of childhood asthma or childhood allergies are not exclusionary.
  • History of nasal or upper respiratory pathology or abnormalities
  • Ongoing, defined as within 30 days of dosing through end of follow-up, usage of nasal spray or nasal drops
  • Treatment with an experimental device or compound within 30 days of the first dose of study drug.
  • Treatment within 30 days of the first dose of the study medication or planned use within the study period with immunomodulator or immunosuppressant agent or medicines over-the-counter (OTC), herbal, prescription, or supplement) with significant activity in the respiratory tract.
  • Pregnancy, anticipated pregnancy, or breastfeeding/lactating
  • Alcohol or drug abuse/dependency (defined as more than 10 standard drinks per week or more than 4 standard drinks on any one day, where 1 standard drink is 10 g of pure alcohol) within 3 months prior to screening.
  • Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at investigator discretion. Tobacco or nicotine consumption is not permitted from screening and until the end of follow-up.
  • Positive alcohol breath test. Repeat test is allowed at investigator discretion.
  • Individuals unable or unwilling to provide adequate informed consent
  • COVID-19 positive
  • Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.

Treatment and study plan

LMN-301

Biological

Intranasally administered powder.

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Daily for 28 days

    All adverse events (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 serious adverse events (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.

  2. Number of Participants Discontinuing From the Study

    Time frame: For 28 days after the first dose of LMN-301

    The endpoint is the number of participants discontinuing from the study.

  3. Changes From Baseline of Systolic and Diastolic Blood Pressure.

    Time frame: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

    Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics.

  4. Changes From Baseline of Pulse Rate.

    Time frame: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

    Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.

  5. Changes From Baseline of Oral Temperature.

    Time frame: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

    Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics.

  6. Changes From Baseline of Hemoglobin.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like hemoglobin. 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.

  7. Changes From Baseline of Respiratory Rate.

    Time frame: In part A respiratory rate is measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

    Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics.

  8. Changes From Baseline of Hematocrit.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures such as hematocrit. 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.

  9. Change From Baseline in Platelets (10^9/L)

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures such as platelets. 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.

  10. Change From Baseline in Neutrophils.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like neutrophils. 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.

  11. Change From Baseline of Alkaline Phosphatase.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures such as alkaline phosphatase. 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.

  12. Change From Baseline in Alanine Transaminase.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like alanine transaminase. 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.

  13. Change From Baseline in Asparate Aminotransferase.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like asparate aminotransferase. 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.

  14. Change From Baseline in Urea.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like urea. 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.

  15. Change From Baseline in Creatinine.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like creatinine. 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.

  16. Change From Baseline in Gamma Glutamyl Transferase.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like gamma glutamyl transferase. 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.

  17. Change From Baseline in Bilirubin.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like bilirubin. 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.

  18. Change From Baseline in Lactate Dehydrogenase.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like lactate dehydrogenase. 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.

  19. Change From Baseline of Prothrombin Intl. Normalized Ratio.

    Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

    Clinical laboratory safety data will be summarized by laboratory measures like prothrombin intl. normalized ratio. 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.

  20. Changes From Baseline of Single RR Heart Rate (Beats/Min).

    Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

    The following ECG parameters will be analyzed: single RR heart rate (beats/min). Observed values and changes from baseline for single RR heart rate (beats/min). will be summarized at each scheduled timepoint using descriptive statistics.

  21. Changes From Baseline of QRS Duration, Single Beat (ms).

    Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

    The following ECG parameters will be analyzed: QRS duration, single beat (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

  22. Change From Baseline in PR Interval, Single Beat (ms).

    Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

    The following ECG parameters will be analyzed: PR interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

  23. Change From Baseline in QTcB Interval, Single-beat (ms)

    Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

    The following ECG parameters will be analyzed: QTcB Interval. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

  24. Change From Baseline in QTcF Interval (ms).

    Time frame: Change from baseline to end of study.

    The following ECG parameters will be analyzed: QTcF Interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

    For QTcF Interval, 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 International Conference of Harmonization (ICH) E14

  25. 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

    The sino-nasal outcome test (SNOT-22) is to measure the consequences of rhinosinusitis. Scores will be totaled for all 22 items. The minimum score on the sinonasal outcome test-22 (SNOT-22) is 0 and the maximum score is 110. Changes from baseline in individual total sinonasal outcome test-22 (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.

Sponsors and collaborators

Lead sponsor

Lumen Bioscience, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 11, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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