COVID-19Phase 1NCT06030414
A Study to Determine the Tolerability of Intranasal LMN-301
A Phase 1 study testing LMN-301 in people with COVID-19, run by Lumen Bioscience, Inc. at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- LMN-301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Oct 2023to 3 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- LMN-301
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMN-301Biological
Intranasally administered powder.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Cohort | Experimental | Not described Receives: Biological: LMN-301 |
| Main Cohort Group 1 | Experimental | Not described Receives: Biological: LMN-301 |
| Main Cohort Group 2 | Experimental | Not described Receives: Biological: LMN-301 |
| Main Cohort Group 3 | Experimental | Not described Receives: Biological: LMN-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
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.
Measured: Daily for 28 days
Number of Participants Discontinuing From the Study
The endpoint is the number of participants discontinuing from the study.
Measured: For 28 days after the first dose of LMN-301
Changes From Baseline of Systolic and Diastolic Blood Pressure.
Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics.
Measured: 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 of Pulse Rate.
Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.
Measured: 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 of Oral Temperature.
Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics.
Measured: 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 of Hemoglobin.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Changes From Baseline of Respiratory Rate.
Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics.
Measured: 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 of Hematocrit.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Platelets (10^9/L)
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Neutrophils.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline of Alkaline Phosphatase.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Alanine Transaminase.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Asparate Aminotransferase.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Urea.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Creatinine.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Gamma Glutamyl Transferase.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Bilirubin.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline in Lactate Dehydrogenase.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Change From Baseline of Prothrombin Intl. Normalized Ratio.
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.
Measured: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Changes From Baseline of Single RR Heart Rate (Beats/Min).
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.
Measured: 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).
Changes From Baseline of QRS Duration, Single Beat (ms).
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.
Measured: 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).
Change From Baseline in PR Interval, Single Beat (ms).
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.
Measured: 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).
Change From Baseline in QTcB Interval, Single-beat (ms)
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.
Measured: 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).
Change From Baseline in QTcF Interval (ms).
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
Measured: Change from baseline to end of study.
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score)
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.
Measured: For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start6 Oct 2023
- Primary completion28 Dec 2023
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030414
- Sponsor's protocol ID
- COV01
- Status last verified
- Jul 2025
- First submitted
- 10 Aug 2023
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06030414
- Acronym / sponsor ID
- COV01
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Posted 30 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sentinel Cohort | Experimental | Biological: LMN-301 |
| Main Cohort Group 1 | Experimental | Biological: LMN-301 |
| Main Cohort Group 2 | Experimental | Biological: LMN-301 |
| Main Cohort Group 3 | Experimental | Biological: LMN-301 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMN-301Intranasally administered powder. | Biological | Main Cohort Group 1, Main Cohort Group 2, Main Cohort Group 3, Sentinel Cohort |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMN-301 in people with COVID-19, run by Lumen Bioscience, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Daily for 28 days). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.