Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects

Inclusion Criteria (part 1):

• Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method
• Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s)
• Subject must agree not to donate semen or ova/oocytes during the study and for 14 days after the last dose of IMP.
• BMI ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.
• Are willing and able to comply with all aspects of the protocol.
• FEV1 ≥80% of the predicted value and FEV1/FVC ratio > 0.70; at screening.
• Able to demonstrate the correct inhalation technique for use of delivery device during the study at screening and pre-dose Day 1.

Inclusion Criteria (part 2):

• Subjects with mild stable asthma with a documented physician confirmed diagnosis of asthma for at least 3 months prior to screening.
• Asthma assessed by investigator as being stable for at least 4 weeks prior to screening and prior to Day 1.
• Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method
• Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s).
• Subject must agree not to donate semen or ova/oocytes during the study and for 14 days after the last dose of IMP.
• Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.
• Are willing and able to comply with all aspects of the protocol.
• Subject is being treated with short acting beta-agonists alone or in conjunction with low to medium doses of ICS.
• Pre-bronchodilator FEV1 ≥70% of the predicted value at screening.
• Able to demonstrate the correct inhalation technique for use of delivery device during the study at screening and pre-dose Day 1.

Inclusion Criteria (part 3):

• Subjects with mild to moderate stable asthma with a documented physician confirmed diagnosis of asthma for at least 3 months prior to screening.
• Asthma assessed by investigator as being stable for at least 4 weeks prior to screening and prior to randomisation.
• Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method .
• Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s)
• Subject must agree not to donate semen or ova/oocytes during the study and for 14 days after the last dose of IMP.
• BMI ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.
• Are willing and able to comply with all aspects of the protocol.
• Subject is being treated with low to medium doses of ICS with or without long-acting beta-agonists.
• Pre-bronchodilator FEV1 ≥70% of the predicted value at screening.
• Able to demonstrate the correct inhalation technique for use of delivery device during the study at screening and pre-dose Day 1, Treatment Period 1.
• Able to produce a sputum sample with a minimum weight of 50 mg at screening.

Exclusion Criteria (part 1):

• Subjects who are Chinese or Japanese.
• Subjects who have received any IMP in a clinical research study within the previous 3 months prior to Day 1.
• Participation in other interventional studies for the duration of the study.
• Subjects who are study site employees or immediate family members of a study site or sponsor employee.
• History of any drug or alcohol abuse in the past 2 years prior to screening.
• Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine depending on type).
• Current tobacco or marijuana smokers and those who have smoked