Created at Source Raw Value Validated value
June 17, 2021, 12:45 a.m. oms

Part A, B & C 1. Volunteers must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adult males and females, 18 to 64 years of age (inclusive) at the screening visit. 3. Be non-smokers (including tobacco, e-cigarettes and marijuana) for a minimum of 3 months prior to participation in the study. Non-smokers with a significant history of smoking (> 5 pack years) are not eligible. 4. Have no history or presence of tuberculosis, asthma, chronic obstructive pulmonary disease or major pulmonary airway disease (participants with history of childhood asthma but no subsequent episodes are eligible). 5. Body Mass Index (BMI) within the range of 18.5 to 30.0 kg/m2 inclusive at the screening visit, and on Day -1, prior to dosing. 6. Medically healthy without clinically significant abnormalities at the screening visit and Day -1, including: a. Physical examination without any clinically relevant findings. b. Systolic blood pressure in the range of 90 to 160 mm Hg (inclusive) and diastolic blood pressure in the range of 50 to 95 mm Hg (inclusive) after 5 minutes in supine position. c. Heart rate in the range of 45 to 100 beats/min (inclusive) after 5 minutes rest in supine position at the screening visit. d. Body temperature, between 35.5°C and 37.7°C (inclusive). e. The screening 12-lead electrocardiogram (ECG) must be within normal range corrected QT interval [QTc] males less than or equal to 450 msec, females less than or equal to 470 msec) or with abnormalities, which are deemed not clinically significant according to the opinion of the Investigator at the screening visit. f. No clinically relevant findings in serum chemistry, haematology, coagulation and urinalysis examinations as judged by the Investigator at screening. g. Pulmonary assessments must be within the normal range at the screening visit and on Day -1, prior to dosing (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio greater than or equal to 80% of normal values, forced expiratory flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted, h. oxygen saturation monitor greater than or equal to 95%). 7. Normal chest x-ray indicating no significant anomaly at the screening visit. 8. Negative cotinine, drug and alcohol tests at screening and Day -1. 9. Female volunteers must: a. Be of non-child-bearing potential i.e. surgically sterilised (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 and a follicle-stimulating hormone level > 40 IU/L at the screening visit), or b. If of childbearing potential, must have a negative pregnancy test at Screening and before the first study drug administration (Day -1). They must agree not to attempt to become pregnant must not donate ova, and must agree to use 2 forms of a highly effective contraceptive method for penile-

Part A, B & C 1. Volunteers must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adult males and females, 18 to 64 years of age (inclusive) at the screening visit. 3. Be non-smokers (including tobacco, e-cigarettes and marijuana) for a minimum of 3 months prior to participation in the study. Non-smokers with a significant history of smoking (> 5 pack years) are not eligible. 4. Have no history or presence of tuberculosis, asthma, chronic obstructive pulmonary disease or major pulmonary airway disease (participants with history of childhood asthma but no subsequent episodes are eligible). 5. Body Mass Index (BMI) within the range of 18.5 to 30.0 kg/m2 inclusive at the screening visit, and on Day -1, prior to dosing. 6. Medically healthy without clinically significant abnormalities at the screening visit and Day -1, including: a. Physical examination without any clinically relevant findings. b. Systolic blood pressure in the range of 90 to 160 mm Hg (inclusive) and diastolic blood pressure in the range of 50 to 95 mm Hg (inclusive) after 5 minutes in supine position. c. Heart rate in the range of 45 to 100 beats/min (inclusive) after 5 minutes rest in supine position at the screening visit. d. Body temperature, between 35.5°C and 37.7°C (inclusive). e. The screening 12-lead electrocardiogram (ECG) must be within normal range corrected QT interval [QTc] males less than or equal to 450 msec, females less than or equal to 470 msec) or with abnormalities, which are deemed not clinically significant according to the opinion of the Investigator at the screening visit. f. No clinically relevant findings in serum chemistry, haematology, coagulation and urinalysis examinations as judged by the Investigator at screening. g. Pulmonary assessments must be within the normal range at the screening visit and on Day -1, prior to dosing (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio greater than or equal to 80% of normal values, forced expiratory flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted, h. oxygen saturation monitor greater than or equal to 95%). 7. Normal chest x-ray indicating no significant anomaly at the screening visit. 8. Negative cotinine, drug and alcohol tests at screening and Day -1. 9. Female volunteers must: a. Be of non-child-bearing potential i.e. surgically sterilised (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 and a follicle-stimulating hormone level > 40 IU/L at the screening visit), or b. If of childbearing potential, must have a negative pregnancy test at Screening and before the first study drug administration (Day -1). They must agree not to attempt to become pregnant must not donate ova, and must agree to use 2 forms of a highly effective contraceptive method for penile-