Bronchiectasis AdultPhase 2NCT07731919
Study on Doses of Inhaled ALX1 in Adults With Bronchiectasis
A Phase 2 study testing ALX1 in people with Bronchiectasis Adult, run by Vast Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- ALX1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Able to reproducibly perform spirometry manoeuvres (i.e., able to perform at least 3 acceptable forced expiratory curves based on the PI's assessment).
- History of at least one exacerbation treated with a course of antibiotics (inhaled, oral or intravenous [IV]) within the 24 months prior to Screening
- Woman of childbearing potential (WOCBP) or fertile man (see definitions in Section 5.3) agrees to use an acceptable method of contraception from the start of Screening until 90 days after the last dose of IP.
Who cannot join
- 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).
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- 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
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Laura MacLean contact
About this study
Official title: A Phase 2a, Placebo-Controlled, Single-Blind, Dose Range-Finding Study of Inhaled ALX1 in Adults With Bronchiectasis
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.
Read the 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.
- Conditions
- Bronchiectasis Adult
- Being tested
- ALX1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX1Drug
Dose Formulation: Solution for inhalation Dose Strength: 28 mg/mL Route of Administration: Inhalation via nebulizer
PlaceboDrug
Dose Formulation: Solution for inhalation Dose Strength: 0.9% sodium chloride Route of Administration: Inhalation via nebulizer
| Study group | Role | What they receive |
|---|---|---|
| ALX1 | Experimental | Not described Receives: Drug: ALX1 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a metHb value ≥ 5% per dose level
Measured: From Day 1 to Day 14 (EOT visit)
Secondary outcomes (10)
Incidence of TEAEs
Measured: From Day 1 to Day 14 (EOT visit)
Incidence of SAEs
Measured: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal vital signs
Measured: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal Laboratory parameters
Measured: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal ECG readings
Measured: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal SpO2
Measured: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal Spirometry Value
Measured: From Day 1 to Day 14 (EOT visit)
Mean change in sputum inflammatory biomarkers per dose level
Active neutrophil elastase, IL-1β, IL-6, IL-8, and TNF-alpha biomarkers assessed via quantitative immunoassay
Measured: From Day 1 to Day 14 (EOT visit)
Mean change in total bacterial load of pathogens per dose level
Assessed by sputum culture and quantitative polymerase chain reaction (qPCR)
Measured: From Day 1 to Day 14 (EOT visit)
Proportion of participants achieving a microbiological culture of pathogens change of at least 1-log CFU/g per dose level
Measured: From Day 1 to Day 14 (EOT visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vast Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731919
- Sponsor's protocol ID
- VST-201
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Placebo-Controlled, Single-Blind, Dose Range-Finding Study of Inhaled ALX1 in Adults With Bronchiectasis
- ClinicalTrials.gov ID
- NCT07731919
- Acronym / sponsor ID
- VST-201
- Conditions
- Bronchiectasis Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Vast TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALX1 | Experimental | Drug: ALX1 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Able to reproducibly perform spirometry manoeuvres (i.e., able to perform at least 3 acceptable forced expiratory curves based on the PI's assessment).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX1Dose Formulation: Solution for inhalation Dose Strength: 28 mg/mL Route of Administration: Inhalation via nebulizer | Drug | ALX1 |
| PlaceboDose Formulation: Solution for inhalation Dose Strength: 0.9% sodium chloride Route of Administration: Inhalation via nebulizer | Drug | Placebo |
Primary outcome
Proportion of participants with a metHb value ≥ 5% per dose level
Time frame: From Day 1 to Day 14 (EOT visit)
10 secondary outcomes
Incidence of TEAEs
Time frame: From Day 1 to Day 14 (EOT visit)
Incidence of SAEs
Time frame: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal vital signs
Time frame: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal Laboratory parameters
Time frame: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal ECG readings
Time frame: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal SpO2
Time frame: From Day 1 to Day 14 (EOT visit)
Proportion of participants with abnormal Spirometry Value
Time frame: From Day 1 to Day 14 (EOT visit)
Mean change in sputum inflammatory biomarkers per dose level
Time frame: From Day 1 to Day 14 (EOT visit)
Mean change in total bacterial load of pathogens per dose level
Time frame: From Day 1 to Day 14 (EOT visit)
Proportion of participants achieving a microbiological culture of pathogens change of at least 1-log CFU/g per dose level
Time frame: From Day 1 to Day 14 (EOT visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura MacLean contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALX1 in people with Bronchiectasis Adult, run by Vast Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Bruinenberg, MD (+1 201-312-0988, pbruinenberg@vasttherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a metHb value ≥ 5% per dose level (time frame: From Day 1 to Day 14 (EOT visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.