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

Summary

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.

Timeline

Start

2025-01-15

Primary completion

2025-05-20

Completion

2025-06-07

Drugs

Indications