Study on Doses of Inhaled ALX1 in Adults With Bronchiectasis
ConditionBronchiectasis Adult
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVast Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Current sputum producer with a history of chronic expectoration that, in the opinion of the Investigator, will be able to continue to reliably provide sputum throughout the study.
Confirmed diagnosis of BE per high-resolution computed tomography (HRCT) prior to Screening due to any of the following: NCFB, CF, primary ciliary dyskinesia, or COPD.
Clinical history consistent with BE (cough, daily chronic sputum production, and/or recurrent respiratory infections).
FEV1 ≥ 40% of predicted values at Screening.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ALX1
DrugDose Formulation: Solution for inhalation Dose Strength: 28 mg/mL Route of Administration: Inhalation via nebulizer
Placebo
DrugDose Formulation: Solution for inhalation Dose Strength: 0.9% sodium chloride Route of Administration: Inhalation via nebulizer
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: ALX1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with a metHb value ≥ 5% per dose level
Time frame
From Day 1 to Day 14 (EOT visit)Secondary outcomes
1
Incidence of TEAEs
Time frame
From Day 1 to Day 14 (EOT visit)2
Incidence of SAEs
Time frame
From Day 1 to Day 14 (EOT visit)3
Proportion of participants with abnormal vital signs
Time frame
From Day 1 to Day 14 (EOT visit)4
Proportion of participants with abnormal Laboratory parameters
Time frame
From Day 1 to Day 14 (EOT visit)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: