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 uninfectedindividuals. This study aims to assess whether the formulation will cause irritation whenadministered in the nose, and how long its protective effects will last.Thirty five healthy adult volunteers will participate in this study.
Not Provided
Biological: LMN-301
Intranasally administered powder.
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 follicle stimulating
hormone (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.
CMAX Clinical Research
Adelaide 2078025, South Australia 2061327, Australia
Not Provided