Study on Doses of Inhaled ALX1 in Adults With Bronchiectasis
brief summary
This study will evaluate the safety and effects of ALX1, an inhaled investigational treatment, in adults with bronchiectasis. Participants will receive either ALX1 or a placebo (a treatment with no active medicine) for 14 days. The study will compare different dose levels of ALX1 to help identify appropriate doses for future research based on safety, tolerability, and changes in predictive biomarkers.
detailed description
This is a Phase 2a, multicentre, placebo-controlled, single-blind, dose range-finding study will assess the safety, tolerability, pharmacodynamics (PD), and preliminary efficacy of inhaled ALX1 or placebo administered for 14 days in adult participants with bronchiectasis. 28 participants will be enrolled and assigned to one of four cohorts. The total duration of study participation will be up to 53 days, including Pre-screening and Screening of approximately 32 days, a Treatment Period of approximately 14 days, and a Follow-up of approximately 1 day following the last dose.
official title
A Phase 2a, Placebo-Controlled, Single-Blind, Dose Range-Finding Study of Inhaled ALX1 in Adults With Bronchiectasis