Phase 1
N=35
A Study to Determine the Tolerability of Intranasal LMN-301
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT06030414 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants With Adverse Events — 5; 9; 10; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LMN-301 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lumen Bioscience, Inc.
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 9; 10; 8 | — |
| PRIMARY Number of Participants Discontinuing From the Study |
0; 0; 1; 0 | — |
| PRIMARY Changes From Baseline of Systolic and Diastolic Blood Pressure. |
1.4; -1.3; -2.4; 0.4; -1.7; -2.8 | — |
| PRIMARY Changes From Baseline of Pulse Rate. |
-4.2; -5.0; -3.0; -4.8; -5.4; -4.6 | — |
| PRIMARY Changes From Baseline of Oral Temperature. |
-0.15; -0.04; 0.13; -0.42; 0.01; -0.1 | — |
| PRIMARY Changes From Baseline of Hemoglobin. |
2.6; 0; -2.8; -1.3; -1.5; 0 | — |
| PRIMARY Changes From Baseline of Respiratory Rate. |
-0.5; -3.1; -0.3; -3.6; 0.3; -2.9 | — |
| PRIMARY Changes From Baseline of Hematocrit. |
0.016; 0; -0.010; -0.008; -0.011; 0 | — |
| PRIMARY Change From Baseline in Platelets (10^9/L) |
2.0; 0; -5.4; -7.3; -4.4; 0 | — |
| PRIMARY Change From Baseline in Neutrophils. |
0.56; 0; -0.33; 0.43; 0; -0.33 | — |
| PRIMARY Change From Baseline of Alkaline Phosphatase. |
2.2; 0; -0.9; -0.8; -2.6; 0 | — |
| PRIMARY Change From Baseline in Alanine Transaminase. |
-0.4; 0; -0.9; -0.8; -2.6; 0 | — |
| PRIMARY Change From Baseline in Asparate Aminotransferase. |
-1.0; 0; -0.8; -1.6; -2.1; 0 | — |
| PRIMARY Change From Baseline in Urea. |
-0.42; 0; -0.25; -0.71; -0.27; 0 | — |
| PRIMARY Change From Baseline in Creatinine. |
-2.8; 0; 0.8; 1.0; -0.5; 0 | — |
| PRIMARY Change From Baseline in Gamma Glutamyl Transferase. |
-0.6; 0; -1.1; -0.1; -0.6; 0 | — |
| PRIMARY Change From Baseline in Bilirubin. |
-1.0; 0; 1.9; -0.5; 1.2; 0 | — |
| PRIMARY Change From Baseline in Lactate Dehydrogenase. |
-0.8; 0; -7.4; -13.2; -12.3; 0 | — |
| PRIMARY Change From Baseline of Prothrombin Intl. Normalized Ratio. |
-0.06; 0; 0.01; -0.03; 0.01; 0 | — |
| PRIMARY Changes From Baseline of Single RR Heart Rate (Beats/Min). |
5.00; 3.08; 0.54; 2.29 | — |
| PRIMARY Changes From Baseline of QRS Duration, Single Beat (ms). |
2.06; 2.24; 0.38; -1.95 | — |
| PRIMARY Change From Baseline in PR Interval, Single Beat (ms). |
-4.94; -0.51; 1.06; -1.53 | — |
| PRIMARY Change From Baseline in QTcB Interval, Single-beat (ms) |
0.78; 4.08; -2.38; -1.44 | — |
| PRIMARY Change From Baseline in QTcF Interval (ms). |
-4.54; 0.92; -2.91; -3.47 | — |
| PRIMARY Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) |
2.6; 1.9; 1.4; 1.1; -1.0; -2.1 | — |
Summary
LMN-301 is to prevent infection by severe acute respiratory syndrome-corona virus (SARS-CoV-2) (the virus causing coronavirus disease of 2019 (COVID-19) in uninfected individuals. This study aims to assess whether the formulation will cause irritation when administered in the nose, and how long its protective effects will last.
Thirty five healthy adult volunteers will participate in this study.
Eligibility Criteria
Individuals must meet all the following criteria to be eligible to participate in this study:
- Adult (between 18 and 65 years of age) at screening
- BMI ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening.
- General good health, without significant medical illness or abnormal physical examination findings per investigator discretion.
- No clinically significant laboratory values at screening for haematology, serum chemistry, coagulation, and urinalysis in the opinion of the Investigator. A repeat test is allowed at the investigator's discretion.
- Normal electrocardiogram (ECG) with no QTcF prolongation.
- Must have provided written informed consent to participate in the clinical trial before any study-related activities are carried out and, in the Investigator's opinion, must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- In the investigator's opinion, participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Female volunteers:
- Must be of non-child-bearing potential, i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause (confirmed with follicle stimulating hormone (FSH) testing), or
- If of child-bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test before the first study drug administration. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use a highly effective method of contraception from signing consent, throughout the study and for at least 30 days after the last dose of study drug. For contraception guidelines see Appendix 4.
- Male volunteers must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 4) from signing consent, during the study, and at least 90 days after the last dose of study drug.
Exclusion Criteria
Individuals will be excluded from this study if they meet any of the following criteria:
- History or presence of clinically significant disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease, including any acute illness or surgery within the past 3 months prior to screening determined by the PI to be clinically relevant.
- Known allergy or previous anaphylaxis to any components of the investigational product
- Allergies, history of allergic disease or chronic respiratory diseases including mild asthma. History of childhood asthma or childhood allergies are not exclusionary.
- History of nasal or upper respiratory pathology or abnormalities
- Ongoing, defined as within 30 days of dosing through end of follow-up, usage of nasal spray or nasal drops
- Treatment with an experimental device or compound within 30 days of the first dose of study drug.
- Treatment within 30 days of the first dose of the study medication or planned use within the study period with immunomodulator or immunosuppressant agent or medicines over-the-counter (OTC), herbal, prescription, or supplement) with significant activity in the respiratory tract.
- Pregnancy, anticipated pregnancy, or breastfeeding/lactating
- Alcohol or drug abuse/dependency (defined as more than 10 standard drinks per week or more than 4 standard drinks on any one day, where 1 standard drink is 10 g of pure alcohol) within 3 months prior to screening.
- Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at investigator discretion. Tobacco
Data sourced from ClinicalTrials.gov (NCT06030414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.