Trials Sponsors Conditions Drugs Pricing

Conditions

Bronchiectasis Adult

Outcome Measures

Primary Outcomes (1)

Proportion of participants with a metHb value ≥ 5% per dose level
From Day 1 to Day 14 (EOT visit)

Secondary Outcomes (10)

Incidence of TEAEs
From Day 1 to Day 14 (EOT visit)
Incidence of SAEs
From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal vital signs
From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal Laboratory parameters
From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal ECG readings
From Day 1 to Day 14 (EOT visit)
+5 more secondary outcomes

Study Arms (2)

ALX1

EXPERIMENTAL

Drug: ALX1

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALX1Drug

Dose Formulation: Solution for inhalation Dose Strength: 28 mg/mL Route of Administration: Inhalation via nebulizer

ALX1

PlaceboDrug

Dose Formulation: Solution for inhalation Dose Strength: 0.9% sodium chloride Route of Administration: Inhalation via nebulizer

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Vast Therapeutics
Industrylead

Central Study Contacts

Paul Bruinenberg, MD

CONTACT

+1 201-312-0988 pbruinenberg@vasttherapeutics.com

Laura MacLean

CONTACT

LMacLean@vasttherapeutics.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

March 31, 2027

You may not qualify if:

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:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN)
Creatinine \> 1.5 × ULN
+2 more criteria

Study on Doses of Inhaled ALX1 in Adults With Bronchiectasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

ALX1

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

ALX1

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record