Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers and Adults With Asthma

Exclusion Criteria

• •1. Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing on this study
• •2. Subjects who have previously received IMP in this study. Subjects who have participated in Part 1 are not permitted to participate in Part 2 or Part 3.
• •3. History of any drug or alcohol abuse in the past 2 years prior to screening.
• •4. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• •5. Females of childbearing potential who are pregnant or lactating, or who plan to become pregnant during the study (all female subjects must have a negative pregnancy test at screening). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or is postmenopausal (had no menses for 12 months without an alternative medical cause (will be re-assessed at admission/pre-dose).
• •6. Positive drugs of abuse test result at screening or admission
• •7. Subjects with congestive heart failure or a history of congestive heart failure
• •8. History of severe cough or bronchospasm upon inhalation of any dry powder inhalation product
• •9. Subjects who are taking or have taken any herbal remedies or CYP3A4 inducers in the 28 days prior to the first IMP administration
• •10. Upper respiratory tract infection (excluding otitis media), fever, acute or chronic cough within 14 days of the first IMP administration, or lower respiratory tract infection within the last 3 months prior to IMP administration
• •11. Recent (last 4 weeks prior to IMP administration) clinically significant bacterial, viral or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals or antifungals; topical treatments, other than antifungals, are allowed.