Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

Exclusion Criteria

• •1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
• •2. History or presence of clinically significant medical condition(s) (including ongoing active infections) or psychiatric condition(s) or disease(s) in the opinion of the PI.
• •3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• •4. Abnormal spirometry test results, in the opinion of the PI.
• •5. History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product.
• •6. History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
• •7. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine®, Topleucon™).
• •8. Clinically significant history or presence of ECG abnormalities such as second- or third degree atrioventricular block, evidence, or family history of prolonged QT syndrome.
• •9. Allergy to bandaids, adhesive dressing, or medical tape.
• •10. Positive urine drug at screening or check in.
• •11. Positive alcohol test at check-in.
• •12. Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
• •13. Positive urine cotinine at screening and check-in.
• •14. Positive results at screening for HIV, HBsAg, or HCV.
• •15. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
• •16. Seated heart rate is lower than 45 bpm or higher than 99 bpm at screening.
• •17. QTcF interval is \>430 msec (males) or \>450 msec (females) at screening or deemed clinically abnormal by the PI.
• •18. Unable to refrain from or anticipates the use of:
• •* Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing in Part 1 or prior to the first dose in Part 2, and throughout the study. Hormone replacement therapy (HRT) is not permitted in this study and within 3 months prior to screening. During the study paracetamol (up to 2 g per 24 hours) may be administered at the discretion of the PI.
• •* Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to dosing in Part 1 or prior to the first dose in Part 2, and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/PD interaction with study drug.
• •19. Have been on a diet incompatible with the on study diet, in the opinion of the PI, within the 28 days prior to the first dose of study drug, and throughout the study.
• •20. Haemoglobin or total WBC outside the normal range at screening.
• •21. Donation of blood or plasma within 90 days prior to dosing in Part 1 or prior to the first dose in Part 2.
• •22. Donation of bone marrow within the last 6 months prior to dosing in Part 1 or prior to the first dose in Part 2.
• •23. Participation in another clinical trial within 90 days prior to dosing in Part 1 or prior to the first dose in Part 2.