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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Cohort | Experimental |
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| Main Cohort Group 1 | Experimental |
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| Main Cohort Group 2 | Experimental |
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| Main Cohort Group 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMN-301 | Biological | Intranasally administered powder. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily for 28 days |
| Number of Participants Discontinuing From the Study | The endpoint is the number of participants discontinuing from the study. | 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. | 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. | 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. |
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Individuals must meet all the following criteria to be eligible to participate in this study:
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.
9. 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentinel Cohort | Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril) |
| FG001 | Main Cohort Group 1 | Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total) |
| FG002 | Main Cohort Group 2 | Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total) |
| FG003 | Main Cohort Group 3 | Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Healthy adult volunteers aged 19-65, with BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sentinel Cohort | Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril) |
| BG001 | Main Cohort Group 1 | Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Daily for 28 days |
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28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sentinel Cohort | Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director | Lumen Bioscience | 206-899-1904 | trials@lumen.bio |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2023 | Mar 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2024 | Mar 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28 |
| BG002 | Main Cohort Group 2 | Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total) |
| BG003 | Main Cohort Group 3 | Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total) |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Main Cohort Group 1 |
Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total) |
| OG002 | Main Cohort Group 2 | Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total) |
| OG003 | Main Cohort Group 3 | Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total) |
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| Primary | Number of Participants Discontinuing From the Study | The endpoint is the number of participants discontinuing from the study. | Posted | Count of Participants | Participants | For 28 days after the first dose of LMN-301 |
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| Primary | 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. | Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg. | Posted | Mean | Standard Deviation | Delta from baseline blood pressure(mmHg) | 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. |
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| Primary | Changes From Baseline of Pulse Rate. | Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics. | Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg. | Posted | Mean | Standard Deviation | Change from baseline of pulse rate | 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. |
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| Primary | Changes From Baseline of Oral Temperature. | Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics. | Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg. | Posted | Mean | Standard Deviation | Change from baseline of temperature (°C) | 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. |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Changes from baseline of hemoglobin(g/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | Changes From Baseline of Respiratory Rate. | Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics. | Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg. | Posted | Mean | Standard Deviation | Respiratory rate (breaths per minute) | 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. |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Hematocrit (g/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Platelets (10^9 cells/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Neutrophils (10^9 cells/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Alkaline Phosphatase (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Alanine Transaminase (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Asparate aminotransferase (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Urea (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Creatinine (umol/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Gamma Glutamyl Transferase (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Bilirubin (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Lactate Dehydrogenase (U/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Prothrombin Intl. Normalized Ratio | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 |
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| Primary | 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. | The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28. | Posted | Mean | Standard Deviation | Single RR heart rate (beats/min) | 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). |
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| Primary | 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. | The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28. | Posted | Mean | Standard Deviation | QRS duration, single beat (ms) | 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). |
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| Primary | 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. | The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28. | Posted | Mean | Standard Deviation | PR Interval, single beat (ms) | 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). |
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| Primary | 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. | The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28. | Posted | Mean | Standard Deviation | QTcB Interval, Single-beat (ms) | 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). |
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| Primary | 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 | The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28. | Posted | Mean | Standard Deviation | QTcF Interval (ms) | Change from baseline to end of study. |
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| Primary | 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. | There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint. | Posted | Mean | Standard Deviation | Sinonasal outcome test-22 scores | For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Main Cohort Group 1 | Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total) | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | Main Cohort Group 2 | Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total) | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Main Cohort Group 3 | Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total) | 0 | 10 | 0 | 10 | 8 | 10 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Viral upper respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Ansomnia | Nervous system disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Hyposmia | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Nasuea | Gastrointestinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Neotrophil count decreased | Investigations | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Rhinitis atrophic | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Exercise tolerance decreased | General disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 27, CTCAE 5.0 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose |
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| Change from baseline in systolic blood pressure (mmHg) - Day 1, 1 hour post-dose |
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| Change from baseline in systolic blood pressure (mmHg) - Day 1, 4 hours post-dose |
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| Change from baseline in systolic blood pressure (mmHg) - Day 2 |
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| Change from baseline in systolic blood pressure (mmHg) - Day 3 |
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| Change from baseline in systolic blood pressure (mmHg) - Day 4 |
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| Change from baseline in systolic from baseline in blood pressure (mmHg) - Day 7 |
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| Change from baseline in systolic change from baseline in blood pressure (mmHg) - Day 8 |
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| Change from baseline in systolic blood pressure (mmHg) - Day 10 |
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| Change from baseline in systolic blood pressure (mmHg) - Day 11 |
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| Change from baseline in systolic blood pressure (mmHg) - Day 14 |
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| Change from baseline in systolic blood pressure (mmHg) - Day 28 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 1, 1 hour post-dose |
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| Change from baseline in diastolic blood pressure - Day 1, 4 hours post-dose |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 2 post-dose |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 3 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 4 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 7 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 8 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 10 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 11 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 14 |
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| Change from baseline in diastolic blood pressure (mmHg) - Day 28 |
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| Change from baseline in pulse rate (beats/min ) - Day 1, 0.5 hour post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 1, 1 hour post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 1, 4 hours post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 2 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 3 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 4 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 7 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 8 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 10 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 11 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 14 post-dose |
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| Change from baseline in pulse rate (beats/min ) - Day 28 post-dose |
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| Change from baseline in temperature Change from baseline in (°C) - Day 1, 0.5 hour post-dose |
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| Change from baseline in temperature (°C) - Day 1, 1 hour post-dose |
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| Change from baseline in temperature (°C) - Day 1, 4 hour post-dose |
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| Change from baseline in temperature (°C) - Day 2 post-dose |
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| Change from baseline in temperature (°C) - Day 3 post-dose |
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| Change from baseline in temperature (°C) - Day 4 post-dose |
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| Change from baseline in temperature (°C) - Day 7 post-dose |
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| Change from baseline in temperature (°C) - Day 8 post-dose |
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| Change from baseline in temperature (°C) - Day 10 post-dose |
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| Change from baseline in temperature (°C) - Day 11 post-dose |
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| Change from baseline in temperature (°C) - Day 14 post-dose |
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| Change from baseline in temperature (°C) - Day 28 post-dose |
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| Change from baseline in hemoglobin (g/L) Day 3 |
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| Change from baseline in hemoglobin (g/L) Day 4 |
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| Change from baseline in hemoglobin (g/L) Day 7 |
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| Change from baseline in hemoglobin (g/L) Day 8 |
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| Change from baseline in hemoglobin (g/L) Day 14 |
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| Change from baseline in hemoglobin (g/L) Day 28 |
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| Change from baseline in Respiratory Rate (breaths/minute) - Day 1, 0.5 hour post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 1, 1 hours post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 1, 4 hours post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 2 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 3 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 4 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 7 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 8 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 10 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 11 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 14 post-dose |
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| Change from baseline in respiratory rate (breaths/minute) - Day 28 post-dose |
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| Change from baseline in hematocrit (L/L) Day 3 |
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| Change from baseline in hematocrit (L/L) Day 4 |
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| Change from baseline in hematocrit (L/L) Day 7 |
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| Change from baseline in hematocrit (L/L) Day 8 |
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| Change from baseline in hematocrit (L/L) Day 14 |
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| Change from baseline in hematocrit (L/L) Day 28 |
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| Change from baseline in platelets (10^9/L) Day 3 |
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| Change from baseline in platelets (10^9/L) Day 4 |
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| Change from baseline in platelets (10^9/L) Day 7 |
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| Change from baseline in platelets (10^9/L) Day 8 |
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| Change from baseline in platelets (10^9/L) Day 14 |
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| Change from baseline in platelets (10^9/L) Day 28 |
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| Change from baseline in neutrophils (10^9/L) Day 3 |
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| Change from baseline in neutrophils (10^9/L) Day 4 |
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| Change from baseline in neutrophils (10^9/L) Day 7 |
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| Change from baseline in neutrophils (10^9/L) Day 8 |
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| Change from baseline in neutrophils (10^9/L) Day 14 |
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| Change from baseline in neutrophils (10^9/L) Day 28 |
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| Change from baseline in alkaline phosphatase (U/L) Day 3 |
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| Change from baseline in alkaline phosphatase (U/L) Day 4 |
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| Change from baseline in alkaline phosphatase (U/L) Day 7 |
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| Change from baseline in alkaline phosphatase (U/L) Day 8 |
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| Change from baseline in Alkaline Phosphatase (U/L) Day 14 |
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| Change from baseline in alkaline phosphatase (U/L) Day 28 |
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| Change from baseline in alanine transaminase (U/L) Day 3 |
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| Change from baseline in alanine transaminase (U/L) Day 4 |
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| Change from baseline in alanine transaminase (U/L) Day 7 |
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| Change from baseline in alanine transaminase (U/L) Day 8 |
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| Change from baseline in alanine transaminase (U/L) Day 14 |
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| Change from baseline in alanine transaminase (U/L) Day 28 |
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| Change from baseline in asparate aminotransferase (U/L) Day 3 |
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| Change from baseline in asparate aminotransferase (U/L) Day 4 |
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| Change from baseline in asparate aminotransferase (U/L) Day 7 |
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| Change from baseline in asparate aminotransferase (U/L) Day 8 |
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| Change from baseline in asparate aminotransferase (U/L) Day 14 |
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| Change from baseline in asparate aminotransferase (U/L) Day 28 |
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| Change from baseline in urea (U/L) Day 3 |
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| Change from baseline in urea (U/L) Day 4 |
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| Change from baseline in urea (U/L) Day 7 |
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| Change from baseline in urea (U/L) Day 8 |
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| Change from baseline in urea (U/L) Day 14 |
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| Change from baseline in urea (U/L) Day 28 |
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| Change from baseline in creatinine (umol/L) Day 3 |
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| Change from baseline in creatinine (umol/L) Day 4 |
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| Change from baseline in creatinine (umol/L) Day 7 |
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| Change from baseline in Creatinine (umol/L) Day 8 |
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| Change from baseline in creatinine (umol/L) Day 14 |
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| Change from baseline in creatinine (umol/L) Day 28 |
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| Change from baseline in gamma glutamyl transferase (U/L) Day 3 |
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| Change from baseline in gamma glutamyl transferase (U/L) Day 4 |
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| Change from baseline in gamma glutamyl transferase (U/L) Day 7 |
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| Change from baseline in gamma glutamyl transferase (U/L) Day 8 |
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| Change from baseline in gamma glutamyl transferase (U/L) Day 14 |
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| Change from baseline in gamma glutamyl transferase (U/L) Day 28 |
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| Change from baseline in bilirubin (U/L) Day 3 |
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| Change from baseline in bilirubin (U/L) Day 4 |
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| Change from baseline in bilirubin (U/L) Day 7 |
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| Change from baseline in bilirubin (U/L) Day 8 |
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| Change from baseline in bilirubin (U/L) Day 14 |
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| Change from baseline in bilirubin (U/L) Day 28 |
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| Change from baseline in Lactate Dehydrogenase (U/L) Day 3 |
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| Change from baseline in Lactate Dehydrogenase (U/L) Day 4 |
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| Change from baseline in Lactate Dehydrogenase (U/L) Day 7 |
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| from baseline in Lactate Dehydrogenase (U/L) Day 8 |
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| Change from baseline in Lactate Dehydrogenase (U/L) Day 14 |
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| Change from baseline in Lactate Dehydrogenase (U/L) Day 28 |
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| Change from baseline in prothrombin intl. normalized ratio Day 3 |
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| Change from baseline in prothrombin intl. normalized ratio Day 4 |
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| Change from baseline in prothrombin intl. normalized ratio day 7 |
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| Change from baseline in prothrombin intl. normalized ratio Day 8 |
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| Change from baseline in prothrombin intl. normalized ratio day 14 |
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| Change from baseline in prothrombin intl. normalized ratio Day 28 |
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| Change from baseline in single RR heart rate (beats/min) Day 28 |
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| Change from baseline in QRS duration (ms) Day 28 |
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| Change from baseline in PR Interval, single beat (ms) Day 28 |
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| Change from baseline in QTcB Interval, Single-beat (ms) Day 28 |
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| Change from baseline in QTcF Interval (ms) Day 28 |
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| Change from baseline in SNOT-22 scores - Day 7 |
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| Change from baseline in SNOT-22 scores - Day 8 |
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| Change from baseline in SNOT-22 scores - Day 14 |
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| Change from baseline in SNOT-22 scores - Day 28 |
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