A Single-Dose Dose Finding Study of AERO-007
Research type
Research Study
Full title
Two-Part, Single-dose, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilator Effects of AERO-007 Inhalation Solution Using a General Purpose Nebulizer in Healthy Volunteers and Subjects with Chronic Obstructive Pulmonary Disease
IRAS ID
1010731
Contact name
Ahmet Tutuncu
Contact email
Sponsor organisation
AeroRx Therapeutics Inc
Research summary
AeroRx Therapeutics, is developing a new experimental study medication AERO-007 (a combination of AERO-001 and AERO-002 in a liquid solution), for the purpose of providing an alternative treatment for chronic obstructive pulmonary disease (COPD). COPD is a lung disease usually caused by many years of smoking, which results in inflammation of the airways and damage to the small air sacs of the lungs.
It is hoped to help patients who have been diagnosed with COPD (including chronic bronchitis and/or emphysema) by providing a long-term maintenance treatment for airflow obstruction.
The purpose of this study is to determine the optimal doses of AERO-001 and AERO-002 in AERO-007, and to determine whether the drug is safe and well tolerated.
The study is divided into two Parts:
Part 1 - will determine the ideal dose of AERO-001 (LABA) and AERO-002 (LAMA) components in AERO-007 for nebulisation in healthy participants.
Part 2 - will look at the safety and tolerability of nebulised AERO-007 compared to a placebo (dummy’ drug with no active ingredients) in participants with COPD.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0807
Date of REC Opinion
3 Jan 2025
REC opinion
Further Information Favourable Opinion