A Phase 1 interventional study of LMN-1001 in Viral Infections, sponsored by Lumen Bioscience, Inc.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Lumen Bioscience, Inc. · Phase 1, Interventional, and Prevention
The purpose of this study is to optimize the tolerability of LMN-1001 relative to its ability to activate the host immune response. LMN-1001 is an investigational dry powder containing recombinant interferon lambda (IFN-λ).
Researchers will monitor side effects, vital signs, nasal symptoms, physical examination findings, and laboratory test results. Nasal and blood samples will be collected to determine how long LMN-1001 remains in the nose, whether it reaches the bloodstream, whether the body produces antibodies against it, and whether it causes local or whole-body immune responses. Participants will be followed through Day 28.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's planned enrollment of 36 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →Lumen Bioscience, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects of child-bearing potential use effective contraception from screening through 12 weeks after study dosing.
Female volunteers must:
Exclusion Criteria:
Biological: LMN-1001
Biological: LMN-1001
Biological: LMN-1001
Biological: LMN-1001
Biological: LMN-1001
Intranasal Interferon Lambda
The number of solicited AEs and SAEs
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.
Time frame: Through Day 14
Number of unsolicited AEs and SAEs
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.
Time frame: Through Day 14
Changes from baseline for systolic and diastolic blood pressure
Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics
Time frame: Through day 14.
Changes from baseline for pulse rate
Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Through day 14.
Changes from baseline for oral temperature
Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Through day 14.
Changes from baseline for respiratory rate
Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Through day 14.
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.
Time frame: Through day 14.
Changes from baseline of hematocrit.
Clinical laboratory safety data will be summarized by laboratory measures like 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.
Time frame: Through day 14.
Changes from baseline in platelets.
Clinical laboratory safety data will be summarized by laboratory measures like 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.
Time frame: Through day 14.
Changes from baseline in red blood cell (RBC) count
Clinical laboratory safety data will be summarized by laboratory measures like RBC count. 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.
Time frame: Through day 14.
Changes from baseline in white blood cell (WBC) count
Clinical laboratory safety data will be summarized by laboratory measures like WBC count. 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.
Time frame: Through day 14.
Changes from baseline in C-reactive protein
Clinical laboratory safety data will be summarized by laboratory measures like C-reactive protein. 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.
Time frame: Through day 14.
Changes from baseline in chloride.
Clinical laboratory safety data will be summarized by laboratory measures like chloride. 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.
Time frame: Through day 14.
Changes from baseline in sodium
Clinical laboratory safety data will be summarized by laboratory measures like sodium. 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.
Time frame: Through day 14.
Changes from baseline in potassium
Clinical laboratory safety data will be summarized by laboratory measures like potassium. 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.
Time frame: Through day 14.
Changes from baseline in bicarbonate
Clinical laboratory safety data will be summarized by laboratory measures like bicarbonate. 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.
Time frame: Through day 14.
Changes from baseline in Alkaline Phosphatase (ALP)
Clinical laboratory safety data will be summarized by laboratory measures like ALP. 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.
Time frame: Through day 14.
Changes from baseline in Alanine Transaminase (ALT)
Clinical laboratory safety data will be summarized by laboratory measures like ALT. 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.
Time frame: Through day 14.
Changes from baseline in Aspartate Aminotransferase (AST)
Clinical laboratory safety data will be summarized by laboratory measures like AST. 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.
Time frame: Through day 14.
Changes 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.
Time frame: Through day 14.
Changes from baseline in Creatine
Clinical laboratory safety data will be summarized by laboratory measures like creatine. 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.
Time frame: Through day 14.
Changes from baseline in BUN
Clinical laboratory safety data will be summarized by laboratory measures like BUN. 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.
Time frame: Through day 14.
Changes 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.
Time frame: Through day 14.
Changes from baseline in Activated Partial Thromboplastin Time (aPTT)
Clinical laboratory safety data will be summarized by laboratory measures like aPTT. 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.
Time frame: Through day 14.
Changes from baseline in prothrombin time (PT)
Clinical laboratory safety data will be summarized by laboratory measures like PT. 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.
Time frame: Through day 14.
Changes from baseline in 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.
Time frame: Through day 14.
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.
Time frame: Through day 14.
Plan to share: No
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Lumen Bioscience, Inc.