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.
Inclusion Criteria:
Exclusion Criteria:
Negative sputum NEATstik result for neutrophil elastase at Pre-screening.
History of Burkholderia cepacia complex within 2 years prior to Pre-screening and/or detection of any Burkholderia spp. in sputum culture or by polymerase chain reaction (PCR) at Screening.
History of Aspergillus fumigatus requiring treatment within 12 months prior to Pre-screening.
History of non-tuberculosis mycobacteria (NTM) infection requiring treatment within 12 months prior to Screening, or detection of one or more NTM species in sputum by PCR at Screening.
History of bronchospasm with inhaled antibiotics or hypertonic saline.
Haemoptysis exceeding 50 mL of blood from the respiratory tract at any time within 30 days prior to IP administration (Day 1).
Initiated macrolide therapy within 90 days before Screening. Existing stable maintenance with inhaled macrolides is permitted if initiated more than 90 days prior to Screening.
Received inhaled anti-pseudomonal therapy within the last 14 days before Pre-screening. Must be willing to refrain from use of inhaled anti-pseudomonal therapy during the study until completion of the Follow-up video/telephone call.
Received oral antibiotics other than macrolide within 30 days prior to Screening. Must be willing to refrain from use of oral antibiotics during the study until completion of the Follow-up video/telephone call.
Received IV antibiotics within 60 days prior to Screening
Initiation of, or increase in the dose of, inhaled corticosteroids within 90 days prior to Screening. Note: participants may be taking stable inhaled corticosteroids at the time of enrolment but must have initiated treatment more than 90 days prior to Screening
Started any of the following muco-corrective therapies (e.g., nebulised saline, N-acetyl cysteine, Pulmozyme®, etc.) within 30 days prior to Screening. Maintenance with these muco-corrective therapies is permitted if initiated 30 days prior to Screening.
Any of the following laboratory abnormalities at Screening:
QT interval corrected by Fridericia's formula (QTcF) interval > 450 ms for males or > 470 ms for females at Screening, or history of prolonged QT syndrome. PR interval < 200 ms at Screening. Out-of-range values may be repeated twice for confirmation. The mean QTcF and PR intervals of the triplicate ECG recordings will be used to determine qualification.
Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening
pbruinenberg@vasttherapeutics.com+1 201-312-0988
LMacLean@vasttherapeutics.com
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