A Study of Intranasal LMN-1001 in Healthy Adults

NCT07852208 | Not Yet Recruiting Phase 1

• 2 other identifiers: VIR01W911SR-26-9-A005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

LMN-1001; Interferon Lambda; Innate Immunity; Host-Directed Antiviral; Intranasal; Safety; Tolerability; Nasal Mucosa; Immunity; Spirulina

Outcome Measures

Primary Outcomes (27)

• 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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Through day 14.

Study Arms (5)

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

Interventions

LMN-1001 BIOLOGICAL

Intranasal Interferon Lambda

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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.'
• 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

Sponsors & Collaborators

• Lumen Bioscience, Inc.: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

David Saunders, MD, MPH

CONTACT

206-899-1904; trials@lumen.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): November 9, 2026
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): July 24, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)