Clinical trial NCT06030414: A Study to Determine the Tolerability of Intranasal LMN-301
Official title: A Phase 1, Single-site, Open-label Study to Determine the Safety and Tolerability of Single and Multiple Doses of Intranasally Administered LMN-301 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Lumen Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: LMN-301 is to prevent infection by SARS-CoV-2 (the virus causing Covid-19 disease) 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:

1. Adult (between 18 and 65 years of age) at screening
2. BMI ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening.
3. General good health, without significant medical illness or abnormal physical examination findings per investigator discretion.
4. 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.
5. Normal electrocardiogram (ECG) with no QTcF prolongation.
6. 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.
7. 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:

1. 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 FSH testing), or
2. If of child-bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test before the first study drug administration. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use a highly effective method of contraception from signing consent, throughout the study and for at least 30 days after the last dose of study drug. For contraception guidelines see Appendix 4.

   9. Male volunteers must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 4) from signing consent, during the study, and at least 90 days after the last dose of study drug.

   Exclusion Criteria

   Individuals will be excluded from this study if they meet any of the following criteria:
   1. 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.
   2. Known allergy or previous anaphylaxis to any components of the investigational product
   3. Allergies, history of allergic disease or chronic respiratory diseases including mild asthma. History of childhood asthma or childhood allergies are not exclusionary.
   4. History of nasal or upper respiratory pathology or abnormalities
   5. Ongoing, defined as within 30 days of dosing through end of follow-up, usage of nasal spray or nasal drops
   6. Treatment with an experimental device or compound within 30 days of the first dose of study drug.
   7. 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.
   8. Pregnancy, anticipated pregnancy, or breastfeeding/lactating
   9. 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.
   10. Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at investigator discretion. Tobacco or nicotine consumption is not permitted from screening and until the end of follow-up.
   11. Positive alcohol breath test. Repeat test is allowed at investigator discretion.
   12. Individuals unable or unwilling to provide adequate informed consent
   13. COVID-19 positive
   14. Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.

Primary outcomes:
measure: Occurrence of adverse events as assessed by CTCAE v5.0 for 28 days after the first dose of LMN-301
timeFrame: Daily for 28 days
measure: Number of participants discontinuing from the study
timeFrame: For 28 days after the first dose of LMN-301
measure: Changes from baseline vital sign measures (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate)
timeFrame: In part A vital signs are measured on Days 1 (5 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (5 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
measure: Changes from baseline safety laboratory measures (hematology, clinical chemistry and coagulation)
timeFrame: For Part A on Days 1, 2, 8 and 14 and For Part B on Days 1, 3 or 4, 7, 14 and 28
measure: Changes from baseline ECG parameters (PR interval, QRS duration, QTcB, QTcF and ventricular heart rate)
timeFrame: Screening and Day 14
measure: Changes from baseline nasal symptoms using the Sino-Nasal Outcome Test (total score)
timeFrame: For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
References: