Viral InfectionsPhase 1NCT07852208
A Study of Intranasal LMN-1001 in Healthy Adults
A Phase 1 study testing LMN-1001 in people with Viral Infections, run by Lumen Bioscience, Inc. at 1 site in Australia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Infections
- What is being tested?
- LMN-1001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Nov 2026to 24 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults aged > 18 and < 65 years at screening
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a maximum body weight of 120 kg at screening
- General good health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion
- Willing and able to comply with all study activities, assessments, and restrictions through 28 days of follow-up, have provided written informed consent to participate in the clinical trial before any study-related activities are carried out, and, in the PI's opinion, able to understand the full nature and purpose of the trial, including possible risks and adverse effects
- Subjects of child-bearing potential use effective contraception from screening through 12 weeks after study dosing.
- Female volunteers must:
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- Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level >40 IU/L at the screening visit), or
- If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.
- 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 an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug
Who cannot join
- History or presence of clinically significant medical condition or disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease
- Any acute illness or surgery within the past 12 weeks prior to screening determined by the PI to be clinically relevant
- Known allergy or previous anaphylaxis to any components of the study product
- Allergies, a history of allergic conditions, nasal or sinus conditions, upper respiratory conditions, or chronic respiratory conditions, including seasonal allergies and mild asthma (history of childhood asthma or childhood allergies are not exclusionary)
- History of nasal or upper respiratory pathology or abnormalities
- Ongoing (within 28 days of study product administration through end of follow-up) use of nasal spray or drops and/or use of any intranasal spray or drops and/or inhaled product within 28 days prior to study drug administration.'
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- Ongoing (within 28 days of study product administration through end of follow-up) or planned treatment with immunomodulator or immunosuppressant agents or medicines (including over the counter, herbal and prescription drugs and supplements with significant activity in the respiratory tract)
- Treatment with an investigational device or compound within 30 days or 5 half-lives (whichever is longer) prior to study product administration
- Current or planned pregnancy or breastfeeding/lactating
- Tobacco or nicotine use from screening through 28 days of study product administration
- Unable or unwilling to provide adequate informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official title: Trial to Optimize Tolerability and Explore the Pharmacodynamics of Intranasal LMN-1001
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.
- Conditions
- Viral Infections
- Being tested
- LMN-1001
- Keywords
- LMN-1001, Interferon Lambda, Innate Immunity, Host-Directed Antiviral, Intranasal, Safety, Tolerability, Nasal Mucosa, Immunity, Spirulina
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMN-1001Biological
Intranasal Interferon Lambda
| Study group | Role | What they receive |
|---|---|---|
| LMN-1001 single low dose | Experimental | Not described Receives: Biological: LMN-1001 |
| LMN-1001 single medium dose | Experimental | Not described Receives: Biological: LMN-1001 |
| LMN-1001 single high dose | Experimental | Not described Receives: Biological: LMN-1001 |
| LMN-1001 multiple dose daily | Experimental | Not described Receives: Biological: LMN-1001 |
| LMN-1001 every other day dosing | Experimental | Not described Receives: Biological: LMN-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start9 Nov 2026 (estimated)
- Primary completion6 Jun 2027 (estimated)
- Study completion24 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852208
- Sponsor's protocol ID
- VIR01
- Other IDs
- W911SR-26-9-A005
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Optimize Tolerability and Explore the Pharmacodynamics of Intranasal LMN-1001
- ClinicalTrials.gov ID
- NCT07852208
- Acronym / sponsor ID
- VIR01
- Conditions
- Viral Infections
- Keywords
- LMN-1001, Interferon Lambda, Innate Immunity, Host-Directed Antiviral, Intranasal, Safety, Tolerability, Nasal Mucosa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 6 Jun 2027 (estimated)
- Study completion
- 24 Jul 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LMN-1001 single low dose | Experimental | Biological: LMN-1001 |
| LMN-1001 single medium dose | Experimental | Biological: LMN-1001 |
| LMN-1001 single high dose | Experimental | Biological: LMN-1001 |
| LMN-1001 multiple dose daily | Experimental | Biological: LMN-1001 |
| LMN-1001 every other day dosing | Experimental | Biological: LMN-1001 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female adults aged > 18 and < 65 years at screening
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a maximum body weight of 120 kg at screening
- General good health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion
- Willing and able to comply with all study activities, assessments, and restrictions through 28 days of follow-up, have provided written informed consent to participate in the clinical trial before any study-related activities are carried out, and, in the PI's opinion, able to understand the full nature and purpose of the trial, including possible risks and adverse effects
- Subjects of child-bearing potential use effective contraception from screening through 12 weeks after study dosing.
Key exclusion criteria (11 listed)
- History or presence of clinically significant medical condition or disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease
- Any acute illness or surgery within the past 12 weeks prior to screening determined by the PI to be clinically relevant
- Known allergy or previous anaphylaxis to any components of the study product
- Allergies, a history of allergic conditions, nasal or sinus conditions, upper respiratory conditions, or chronic respiratory conditions, including seasonal allergies and mild asthma (history of childhood asthma or childhood allergies are not exclusionary)
- History of nasal or upper respiratory pathology or abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMN-1001Intranasal Interferon Lambda | Biological | LMN-1001 every other day dosing, LMN-1001 multiple dose daily, LMN-1001 single high dose, LMN-1001 single low dose, LMN-1001 single medium dose |
Primary outcome
The number of solicited AEs and SAEs
Time frame: Through Day 14
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.
Number of unsolicited AEs and SAEs
Time frame: Through Day 14
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.
Changes from baseline for systolic and diastolic blood pressure
Time frame: Through day 14.
Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics
Changes from baseline for pulse rate
Time frame: Through day 14.
Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.
Changes from baseline for oral temperature
Time frame: Through day 14.
Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics.
Changes from baseline for respiratory rate
Time frame: Through day 14.
Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics.
Changes from baseline of hemoglobin.
Time frame: Through day 14.
Clinical laboratory safety data will be summarized by laboratory measures like hemoglobin. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Changes from baseline of hematocrit.
Time frame: Through day 14.
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.
Changes from baseline in platelets.
Time frame: Through day 14.
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.
Changes from baseline in red blood cell (RBC) count
Time frame: Through day 14.
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.
Changes from baseline in white blood cell (WBC) count
Time frame: Through day 14.
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.
Changes from baseline in C-reactive protein
Time frame: Through day 14.
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.
Changes from baseline in chloride.
Time frame: Through day 14.
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.
Changes from baseline in sodium
Time frame: Through day 14.
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.
Changes from baseline in potassium
Time frame: Through day 14.
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.
Changes from baseline in bicarbonate
Time frame: Through day 14.
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.
Changes from baseline in Alkaline Phosphatase (ALP)
Time frame: Through day 14.
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.
Changes from baseline in Alanine Transaminase (ALT)
Time frame: Through day 14.
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.
Changes from baseline in Aspartate Aminotransferase (AST)
Time frame: Through day 14.
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.
Changes from baseline in Urea
Time frame: Through day 14.
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.
Changes from baseline in Creatine
Time frame: Through day 14.
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.
Changes from baseline in BUN
Time frame: Through day 14.
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.
Changes from baseline in Bilirubin
Time frame: Through day 14.
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.
Changes from baseline in Activated Partial Thromboplastin Time (aPTT)
Time frame: Through day 14.
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.
Changes from baseline in prothrombin time (PT)
Time frame: Through day 14.
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.
Changes from baseline in Prothrombin Intl. Normalized Ratio.
Time frame: Through day 14.
Clinical laboratory safety data will be summarized by laboratory measures like Prothrombin Intl. Normalized Ratio. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Changes from baseline nasal symptoms using the Sino-Nasal Outcome Test (Total Score)
Time frame: Through day 14.
The sino-nasal outcome test (SNOT-22) is to measure the consequences of rhinosinusitis. Scores will be totaled for all 22 items. The minimum score on the sinonasal outcome test-22 (SNOT-22) is 0 and the maximum score is 110. Changes from baseline in individual total sinonasal outcome test-22 (SNOT-22) scores will be calculated as the post-baseline value minus the baseline value. Thus, a negative change will reflect an improvement in the corresponding score. Observed values and changes from baseline will be summarized at each scheduled timepoint by treatment using descriptive statistics and tabulated for each cohort (dose level) and overall. Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT score will also be included in the listing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMN-1001 in people with Viral Infections, run by Lumen Bioscience, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Saunders, MD, MPH (206-899-1904, trials@lumen.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of solicited AEs and SAEs (time frame: Through Day 14). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.