| Eligibility |
Inclusion Criteria:
1. Subjects who provide written informed consent to participate in the study.
2. Women Of Child-Bearing Potential (WOCBP) who are neither pregnant (as determined by
negative pregnancy test) nor lactating.
3. WOCBP or men, whose partners are WOCBP, who agree to use an effective method of
contraception throughout the study period (including follow-up).
4. Subjects who have no difficulties in receiving drugs by inhalation through a mask and
able to operate the inhalation device after receiving training.
5. Subjects must be able to understand the requirements of the study and must be willing
to comply with the requirements of the study.
6. Men who agree to refrain from donating sperm during the study course and 3 months
after study completion.
Inclusion Criteria for Part A only:
7. Healthy men and women between 18 and 45 (inclusive) years of age.
8. Body Mass Index (BMI) between 19 and 30 kg/m2.
9. Subjects in general good health in the opinion of the investigator, as determined by
medical history, vital signs and a physical examination.
10. No clinically significant abnormalities in hematology, blood chemistry, or urinalysis
laboratory tests at screening.
11. Negative human immunodeficiency virus (HIV), hepatitis B and hepatitis C serology
tests.
12. Screening Forced Expiratory Volume In One Second (FEV1) value of >80% of the predicted
normal value or within the Global Lung Function Initiative (GLI) normal range.
13. Non-smokers (by declaration) for at least 6 months prior to screening.
14. No known history of alcohol abuse and negative blood alcohol test on admission to the
clinical site prior to dosing.
15. No known history of drug abuse, negative urinary screen for drugs of abuse determined
on Screening visit.
16. Willing to be confined in the clinical study facility for approximately 48 hours.
Inclusion Criteria for Part B only:
7. Hospitalized or ambulatory patients, diagnosed as infected with SARS-CoV-2 by PCR, with
no more than 7 days from likely time of exposure (if can be determined) and not more than 5
days from first symptoms, before first treatment.
8. First confirmatory PCR (documented)- no more than 5 days before first dosing.
9. Age: 18-75 years (inclusive). 10. Asymptomatic or presenting any symptoms determined as
either mild or moderate or with Stable Peripheral Oxygen Saturation (SpO2) while receiving
oxygen supplementation, which does not require high-flow nasal administration or assisted
ventilation:
Mild:
- Fever (with or without chills)
- Cough
- Congestion or runny nose
- Sore throat
- Malaise
- Headache
- Muscle pain
- New loss of taste or smell
- Gastrointestinal symptoms (nausea, vomiting , diarrhea)
Moderate:
- Any symptom of mild illness scored as moderate in severity by the study physician
- Shortness of breath with exertion
- Respiratory Rate (RR) <30 breaths per minute
- SpO2 > 93% on room air at sea level
- Heart Rate (HR) = 90 and <125 beats per min
Exclusion Criteria:
1. Subjects who may, in the opinion of the investigator, be exposed to additional risks
by participation in the study, based on medical history, vital signs,
electrocardiogram (ECG), physical examination and safety lab tests.
2. Chronic obstructive or restrictive lung disease or asthma.
3. History of adverse reactions during aerosol delivery of any medicinal product.
4. Subjects unable to cooperate with inhalation by face mask or having facial hair that
prevents the face mask from fitting tightly during inhalation.
5. Subject is mentally or legally incapacitated, or is unable to communicate well with
the investigators and the staff or is likely to be non-compliant or uncooperative
during the study.
Exclusion Criteria for Part A only:
6. Positive SARS-CoV-2 swab test on screening.
7. Any acute illness (e.g. acute infection) within 48 hours prior to the study drug
administration, which is considered of significance by the Investigator.
8. Known contraindication, hypersensitivity and/or allergy to any drug.
9. Sitting Blood Pressure (BP) <90/40 mmHg or >140/90 mmHg at screening.
10. Sitting heart rate (HR) <45 beats per minute (bpm) or > 99 bpm at screening.
11. Use of any prescription or over-the-counter medications, including vitamins, herbal,
or dietary supplements within 14 days prior to dosing. Paracetamol, up to 2g /day is
allowed up to 24 hours prior to dosing. The use of contraceptive drugs is allowed.
12. Donation of blood within 90 days prior to dosing.
13. Currently participating in another clinical trial or participation in another clinical
trial in which a study drug has been administered, within 60 days prior to enrollment.
Exclusion Criteria for Part B only:
6. Likely time from exposure of more than 7 days before first treatment, or having
symptoms, that may be retrospectively attributed to COVID-19, for more than 5 days before
first treatment.
7. Currently participating in another clinical trial related to COVID-19 treatment or
previous participation in a clinical trial in which a study drug has been administered,
within 60 days prior to enrollment, or receiving any experimental treatment for COVID-19
outside the framework of a clinical trial.
8. Patients requiring high-flow nasal oxygen or assisted ventilation. 9. Heavy smoker (>1
pack year), by patient's declaration. 10. FEV1<50% of the predicted normal value. 11.
Patients who are not expected to be able to complete the full experimental treatment
schedule (up to 7 days).
12. Subjects who were vaccinated against or have previously recovered from COVID-19.
13. Known medical history of HIV, hepatitis B, hepatitis C
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