An early-phase clinical study to provide early data on an inhibitor/blocker of an important part of the immune system in the lung

Micro: a Phase 0 experimental medicine study to provide early mechanistic data in humans of NLRP3/1 inflammasome inhibition after direct intrapulmonary dosing of ADS032

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35867933

Enrollment

Registered

2022-12-21

Start date

2023-11-21

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease or bronchiectasis Respiratory

Interventions

Current interventions as of 14/05/2026: This study seeks to test the hypotheses that a novel Clinical Investigational Agent (CIA), ADS032, can attenuate alveolar macrophage inflammasome activity in th

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 14/05/2026: 1. Provision of informed consent 2. Aged at least 18 years old and over 3. Diagnosis of suspected or confirmed ILD or bronchiectasis (Group 1) and ability to have a bronchoscopy 4. Is not participating in a Clinical Trial of an Investigational Medicinal Product (CTIMP) Previous inclusion criteria: 1. Provision of informed consent 2. Aged at least 18 years old and over 3. Diagnosis of suspected or confirmed ILD or bronchiectasis (Group 1) and ability to have a bronchoscopy 4. Patient undergoing surgical resection of lung for a suspected inflammatory, fibrotic or malignant process (Group 2) 5. Is not participating in a Clinical Trial of an Investigational Medicinal Product (CTIMP)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 14/05/2026: 1. Pregnant or breastfeeding 2. Known hypersensitivity to ADS032 3. In the Investigator’s opinion, the patient is unwilling or unable to undergo a bronchoscopy, laboratory tests or other study procedures 4. ILD and bronchiectasis patients receiving steroids or other immunomodulators (defined as any drugs that may suppress the immune system – azathioprine, mycophenolate, ongoing chemotherapy, macrolide antibiotics) Previous exclusion criteria: 1. Pregnant or breastfeeding 2. Known hypersensitivity to ADS032 3. In the Investigator’s opinion, the patient is unwilling or unable to undergo a bronchoscopy, laboratory tests or other study procedures 4. ILD and bronchiectasis patients receiving steroids or other immunomodulators (defined as any drugs that may suppress the immune system – azathioprine, mycophenolate, ongoing chemotherapy, macrolide antibiotics) 5. Already participated in Group 1 of this study

Design outcomes

Primary

Measure	Time frame
To evaluate early mechanistic data following administration of ADS032 assessed by measuring key inflammatory cytokine levels in the lung fluid of suspected or confirmed ILD patient groups measured using a variety of laboratory techniques, for example, ELISA at a single time point post the bronchoscopy	—

Secondary

Measure	Time frame
1. Key exploratory biomarkers and their response will be evaluated (e.g. cytokines, chemokines, cell surface markers) will be measured using a variety of laboratory techniques immediately before the procedure and following the administration of ADS032 at a single time point post bronchoscopy 2. Pharmacokinetics parameters (e.g. quantification) of ADS0132 in blood and urine measured using standard laboratory techniques immediately before the procedure and 4 hours post procedure	—

Measure

Time frame

1. Key exploratory biomarkers and their response will be evaluated (e.g. cytokines, chemokines, cell surface markers) will be measured using a variety of laboratory techniques immediately before the procedure and following the administration of ADS032 at a single time point post bronchoscopy 2. Pharmacokinetics parameters (e.g. quantification) of ADS0132 in blood and urine measured using standard laboratory techniques immediately before the procedure and 4 hours post procedure

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Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026