Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD

Cohort 1 (Healthy Subjects) Inclusion Criteria: * Male or female aged 18 to 55 years * FEV1 \> 80% of predicted normal (using the Global Lung Function Initiative GLI 2012 reference values) * Body mass index \> 18 and \< 32 kg/m2 * Female subjects of childbearing potential must not be pregnant, breast feeding or lactating and use, with their partner, a male condom plus an approved method of highly effective birth control method * Female subjects of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit * Male subjects who are sexually active with a 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 * 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 Exclusion Criteria: * 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 * Lower respiratory tract infection within 6 weeks prior to the Screening Visit * History of malignancy of any organ system, except for localized skin cancers, within 5 years prior to the Screening Visit * Major surgery (requiring general anaesthesia) within 6 weeks prior to the Screening Visit * Positive serum hepatitis B surface antigen (HbsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies * Chronic viral infection or immunodeficiency condition * History of any drug and/or alcohol abuse in the past 2 years * Current or previous use of tobacco, nicotine products or e-cigarettes within 6 months * Smoking history of \> 5 pack years * Regular alcohol consumption in males \>21 units per week and females \>14 units per week * Positive urine drugs of abuse test and/or alcohol breath test * Donation of 450 mL of blood within 8 weeks * Known hypersensitivity to any ingredients in the formulation for AERO-001, AERO-002, and AERO-007 * Participation in another investigational drug study within 30 days, 5 half-lives or twice the duration of the biological effect Cohort 2 (Subjects with COPD) Inclusion Criteria: * Male or female aged 40 to 75 years * Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Report, 2024 for at least 12 months * Post-bronchodilator spirometry (within 30 minutes following 4 puffs of salbutamol) demonstrating the following: * FEV1 \> 40 and \< 80% of predicted normal (using the Global Lung Function Initiative GLI 2012 reference values) * FEV1/FVC ratio \< 0.70 * ≥ 150 mL increase from pre-bronchodilator FEV1 * Ability to change current COPD therapy and discontinue long-acting bronchodilators for the duration of the study and short-acting bronchodilators for 8 hours prior to dosing at each treatment visit * Current or former-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, 10 packs/day for 1 year) * Ability to perform reproducible spirometry according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines * Female subjects of childbearing potential must not be pregnant, breast feeding or lactating and use, with their partner, a male condom plus an approved method of highly effective birth control method * Willing and able to provide written informed consent Exclusion Criteria: * Female subjects who are pregnant, breast-feeding or lactating * Current evidence or recent history of significant comorbidities; including cardiovascular disease (such as myocardial infarction, cardiac failure, uncontrolled hypertension, or life-threatening arrhythmias), uncontrolled diabetes, neurologic, psychiatric, hepatic, renal, immunological, or haematological conditions within the last 6 months * Positive serum HbsAg, HCV Ab or HIV 1 and/or 2 antibodies * Lower respiratory tract infection within 6 weeks * Recent history of hospitalization due to an exacerbation of airway disease or acute worsening of COPD requiring antibiotic or corticosteroid treatment within 6 months * Other respiratory disorders: Current diagnosis of predominant asthma, lung cancer, bronchiectasis, interstitial lung disease, tuberculosis, pulmonary hypertension, or other non-specific pulmonary diseases * Prior lung volume reduction surgery or history of chest/lung irradiation * Daily oxygen therapy for \> 12 hours per day * Body mass index \>35 kg/m2 * Current or recent history of medical conditions that are contraindicated for use of an inhaled LAMA (such as urinary retention or bladder neck obstruction type symptoms, prostatic hypertrophy, or narrow-angle glaucoma) within the last 6 months * Current or recent history (previous 12 months) of excessive use or abuse of alcohol (males \>21 units per week and females \>14 units per week) * Current evidence or history (within the past 2 years) of abusing legal drugs or use of illegal drugs or substances * Donation of 450 mL of blood within 8 weeks * Major surgery (requiring general anaesthesia) within 6 weeks * History of malignancy of any organ system, except for localized skin cancers, within 5 years * Known hypersensitivity to any ingredients in the formulation for AERO-001, AERO-002, and AERO-007 * Participation in another investigational drug study within 30 days, 5 half-lives or twice the duration of the biological effect, whichever is longer