A Phase 2a, Placebo-Controlled, Single-Blind, Dose Range Finding Study of Inhaled ALX1 in Adults with Bronchiectasis (NCT07731919)

This Phase 2a, multicentre, placebo-controlled, single-blind, dose range-finding study will assess the safety, tolerability, pharmacodynamics, and preliminary efficacy of ascending doses of inhaled ALX1 or placebo administered for 14 days in adults with BE. The total duration of study participation for each participant will be up to 53 days, including Pre-screening and Screening of up to 32 (+ 2) days, a Treatment Period of 14 doses over up to 16 (± 1) days, and a Follow-up video or telephone call 1 (+ 1) day after the final dose.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Peter Wark

Key inclusion data

INCLUSION: Male or female adults, aged 18 to 80 years old; Confirmed diagnosis of Bronchiectasis per high-resolution computed tomography (HRCT) prior to Screening due to any of the following: NCFB, CF, primary ciliary dyskinesia, or COPD; History of at least one exacerbation treated with a course of antibiotics (inhaled, oral or intravenous [IV]) within the 24 months prior to Screening; Post bronchodilator FEV1 >40% EXCLUSION: Any lower respiratory specimen yielding a member of the Burkholderia cepacia complex within 2 years prior to Pre-screening; History of Aspergillus fumigatus or non-tuberculosis mycobacteria (NTM) infection requiring treatment within 12 months prior to Pre-screening; History of bronchospasm with inhaled antibiotics or hypertonic saline; Current smoker/ vaping of tobacco or cannabis products (within 3 months before Screening), unless agreeing to abstain (for patients who smoke less or equal to 2 cigarettes/ day or equivalent)