Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

Prior treatment

• Lower respiratory tract infection within 6 weeks prior to the Screening Visit
• Major surgery (requiring general anaesthesia) within 6 weeks prior to the Screening Visit, or planned surgery through the end of the study
• History of any drug and/or alcohol abuse in the past 2 years prior to the Screening Visit
• Current or previous use of tobacco, nicotine products, or e-cigarettes within 6 months prior to the Screening Visit through the End of Study Visit
• Positive urine cotinine test at the Screening Visit or prior to dosing at each Treatment Visit
• Positive urine drugs of abuse test and/or alcohol breath test at the Screening Visit or prior to dosing at each Treatment Visit that cannot be accounted for by concomitant medication, in the opinion of the Investigator
• Participation in another investigational drug study within 30 days of the last dose, 5 average terminal elimination half-lives (T1/2) or twice the duration of the biological effect, whichever is longer, prior to the Screening Visit

Other illness

• History of malignancy of any organ system, except for localized skin cancers, within 5 years prior to the Screening Visit
• Chronic viral infection or immunodeficiency condition
• Smoking history of \> 5 pack years
• History of intolerance or hypersensitivity to any of the ingredients in the formulation for AERO-002 or other aerosol medications

Lab values

• Any condition or abnormality (including medical history, clinical laboratory, ECG, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator or Medical Monitor, would compromise the safety of the participant, or would interfere with or complicate study procedures or assessments
• Positive serum hepatitis B surface antigen (HbsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at the Screening Visit

Other

• Regular alcohol consumption in males \>21 units per week and females \>14 units per week
• Donation of ≥ 450 mL of blood within 8 weeks of the Screening Visit
• History or high risk of noncompliance with study visits and procedures or unsuitable for entry into the study, at the discretion of the Investigator

• Male or female aged 18 to 55 years, inclusive, at the time of informed consent
• Forced expiratory volume in 1 second (FEV1) \> 80% of predicted normal at the Screening Visit (using the Global Lung Function Initiative \[GLI\] 2012 reference values)
• Body mass index \> 18 and \< 32 kg/m2 at the Screening Visit
• Able to abstain from alcohol for 24 hours prior to the Screening Visit, and prior to and after each dosing visit
• Female participants of childbearing potential must not be pregnant, breast feeding, or lactating, and heterosexual female participants of childbearing potential must agree to use, with their partner, a male condom plus an approved method of highly effective birth control from the time of informed consent and for 30 days following the last administered dose
• Female participants of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and a negative urine pregnancy test prior to dosing at each Treatment Visit
• Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a male condom plus an approved method of highly effective contraception from the time of informed consent and for 30 days following the last administered dose
• Participants must agree not to donate semen or ova/oocytes from the time of informed consent and for 30 days following the last administered dose
• Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments at the time of screening, as judged by the Investigator
• Willing and able to provide written informed consent