Study on Doses of Inhaled ALX1 in Adults With Bronchiectasis

NCT07731919 | Not Yet Recruiting Phase 2

• 1 other identifier: VST-201
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

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)

Study Arms (2)

ALX1

EXPERIMENTAL

Drug: ALX1

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALX1 DRUG

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

ALX1

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.

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

Sponsors & Collaborators

• Vast Therapeutics: lead

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 (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share