| Eligibility |
Inclusion Criteria:
1. Male or female and = 18 to = 45 years of age at time of signing the Informed Consent
Form.
2. BMI is between =18.00 to 29.00 kg/m2 with a minimum body weight of 45.0 kg.
3. Participant who is in good health based on the results of medical history, physical
examination, vital sign measurements, and clinical laboratory evaluations, as assessed
by the Investigator (or designee) with a resting heart rate of = 90 beats per minute
and systolic blood pressure of = 130/90 mmHg and diastolic blood pressure of = 90/50
mmHg.
4. Has normal lung function assessed using spirometry and defined by FVC = lower limit of
normal (LLN), FEV1/FVC = LLN, and PIF = LLN. (FVC- Functional Vital Capacity; FEV-
Forced Expiratory Volume)
5. Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
6. Who is a non-smoker; or social smoker who only used nicotine on = 5 occasions within
30 days prior to Screening, a negative cotinine test at Screening, and ability and
willingness to refrain from tobacco products for the duration of the study (from 7
days prior to the first dose through to EOS [Visit 5]).
Exclusion Criteria:
1. Participant who is pregnant or lactating at Screening or planning to become pregnant
(self or partner) at any time during the study (through Visit 5/EOS).
2. Participant has a history of significant hypersensitivity or intolerance to lactose.
3. Participant has a history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, haematological, pulmonary, cardiovascular,
gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as
determined by the Investigator (or designee) except for fully resolved childhood
asthma.
4. Participant has a positive urine drug screen (including cotinine) at Screening and at
Baseline (Visit 2/Day -1).
5. Participant has a positive COVID-19 test at Screening and prior to Baseline (Visit
2/Day -1)
6. Participant took part a clinical study involving administration of an investigational
drug (new chemical entity) in the past 30 days or 5 half-lives prior to Baseline
(Visit 2/Day -1).
7. Participant used or intends to use any prescription or non-prescription
medications/products within 14 days prior to dosing through to Follow-up (Visit 5),
with the exception of Oral contraceptive pill (OCPs) and paracetamol/acetaminophen (1
therapeutic dose [1g] three times per week) at the discretion of the Investigator, and
contraceptives.
8. Participant has a history of alcoholism, substance or drug abuse-related disorders
deemed significant by the Investigator (or designee) (ie, > 14 drinks/week for women
or > 21 drinks/week for men [1 drink = 150 mL of wine or 360 mL of beer or 45 mL of
hard liquor]) within the last 3 months prior to dosing, must not have consumed more
than 14 drinks per week in any week or have a history of alcohol abuse within the last
12 months.
9. Participant has a positive alcohol breath test at Screening and prior to dosing with
Investigational Product (IP) at Visit 2, Visit 3, and Visit 4.
10. Female participant has a positive urine pregnancy test prior to dosing with IP at
Visit 2, Visit, 3, and Visit 4.
11. Participant has a positive test for HIV, hepatitis B surface antigen (HBsAg), or
hepatitis C virus antibody (anti-HCV) with HCV RNA detected at Screening or Day 1 and
hepatitis B core antibody (HBcAb) at Screening only.
12. Participant has presence of any physical or psychological medical condition that, in
the opinion of the Investigator, would make it unlikely that the participant will
comply with the protocol or complete the study per protocol.
13. Participant has received any of the following vaccinations:
1. Live vaccine(s) within 1 month prior to Screening or plans to receive such
vaccines during the study.
2. Killed vaccine 1 week prior to Screening.
3. COVID-19 vaccine Day -7 through to Visit 4.
14. Participant had surgery of the nose/paranasal sinuses/mouth/throat within 8 weeks
prior to Screening.
15. Participant has any clinically relevant respiratory (especially with reduction of
respiratory capacity) or cardiovascular abnormality (eg, high blood pressure,
myocardial infarction in previous 3 months, etc), or any other abnormality that in the
opinion of the Investigator may pose a safety risk to a participant in this study, may
confound the clinical performance or safety assessment, or may interfere with study
participation.
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