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

This is a phase 1/phase 2a, single dose, crossover study conducted in two parts. Part 1: Phase 1, open-label, 4-period crossover study in 8 healthy subjects to determine the optimal dose of AERO-001 and AERO-002, the active components of AERO-007 combo bronchodilator, using the systemic pharmacokinetic (PK) profile. Part 2: Phase 2a, randomized, double-blind, placebo-controlled, 3-period crossover study in 16 subjects with COPD to determine the safety, tolerability, PK, and bronchodilator profile of AERO-007 inhalation solution administered via oral inhalation using a general-purpose nebulizer.

According to the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] guidelines, combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial pharmacotherapy for COPD patients with high symptom severity, frequently experiencing breathlessness and patients with high exacerbation risk. Although there are currently multiple LABA+LAMA combination bronchodilators available in an inhaler (MDI, DPI, and SMI), a significant number of COPD patients, generally high risk and older patients, do not receive optimal benefit from inhalers. Nebulized delivery provides an effective alternative for these patients. Currently there are no approved LABA+LAMA combinations available for nebulization delivery. AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for delivery using a general purpose nebulizer. This study consists of two parts. In Part 1 (Phase 1), 8 healthy subjects will be randomized to receive single doses of 4 study treatments in an open-label, crossover design (low and high doses of AERO-001 and AERO-002). In Part 2 (Phase 2a), 16 subjects with clinically stable COPD will be randomized to receive single doses of 3 study treatments in a double-blind, crossover design (low and high doses of AERO-007 and placebo) administered by random sequence.