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

Phase 1

• Conditions: Interstitial lung disease or bronchiectasis; Respiratory

• Registration Number: ISRCTN35867933
• Lead Sponsor: Accord (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-21
• Last Update Posted: 3 October 2023
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>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