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Research Article | DOI: https://doi.org/10.31579/2693-4779/284
1Baillie Gifford Pandemic Science Hub, Institute for Regeneration and Repair, Edinburgh BioQuarter, The University of Edinburgh, Edinburgh, UK.
2Department of Respiratory Medicine, New Royal Infirmary of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.
3Department of Respiratory Medicine, Western General Hospital, Edinburgh, UK.
*Corresponding Author: Tom Quinn, Baillie Gifford Pandemic Science Hub, Institute for Regeneration and Repair, Edinburgh BioQuarter, The University of Edinburgh, Edinburgh, UK.
Citation: T Quinn, A Bruce, S Dickson, E Gaughan, F Li, et al, (2025), Phase 0 Experimental Medicine Study of Direct Intratarget Pulmonary Microdosing of nlrp3/1 Inflammasome Inhibitor ads032: the Micro Study. A Protocol Paper, Clinical Research and Clinical Trials, 13(5); DOI:10.31579/2693-4779/284
Copyright: © 2025, Tom Quinn. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received: 13 October 2025 | Accepted: 28 October 2025 | Published: 05 November 2025
Keywords: pharmacodynamics; pharmacokinetic; chronic lung disease
Introduction
High attrition in drug development remains a significant challenge for research and development organisations worldwide. Most novel drug compounds fail at an early stage, often without knowledge of target engagement or molecular efficacy at diseased tissue level. Phase 0 trials provide an opportunity to provide mechanistic data in a small number of patients at the earliest stage of clinical development. The Micro study protocol is designed to deliver a microdose (100µg) of a novel inflammasome inhibitor ADS032 directly into the distal lung of patients with inflammatory and fibrotic interstitial lung disease and bronchiectasis with the aims of assessing feasibility, molecular efficacy and pharmacokinetics.
Methods and analysis
ADS032 (100µg) and vehicle will be delivered directly to the distal lung (intratarget microdosing) via a flexible catheter in patients undergoing bronchoscopy. Lung samples will be collected in the form of bronchoalveolar lavage, micro-alveolar lavage, and distal airway brushings Up to 12 patients will be recruited. The study is not randomised. The primary endpoint will be measurement of the inflammasome-pathway mediators IL-1β, TNF-α, LDH, ATP, IL-6 and IL-18 in BAL macrophages in the presence of ADS032. A secondary aim is to determine pharmacokinetic (PK) data for the microdosed drug in blood. Exploratory endpoints will include evaluation of a range of potential inflammasome mediators in other lung samples and PK data in urine and respiratory samples.
Ethics approval, data management and dissemination
The Micro study has received a favourable ethical opinion from South Central Oxford B Research Ethics Committee (REC) and approval from the National Health Service (NHS) Lothian Research and Development (R&D) department. The Medicines and Healthcare Products Regulatory Agency (MHRA) determined that the study is not a Clinical Trial of an Investigational Medicinal Product (CTIMP) and therefore does not require MHRA regulatory oversight. Clinical data management (CDM) will be in accordance with standard National Health Service (NHS) Lothian Research and Development (R&D) regulatory requirements. The results will be submitted for publication in a peer-reviewed journal as soon as possible after recruitment and data analysis is complete.
Registration details
The Micro study is registered with the primary clinical trial register ISRCTN. The record number is ISRCTN35867933.
Highlights
High attrition in drug development remains a significant challenge for research and development (R&D) organisations worldwide. Reducing the attrition rate during clinical drug development is among the key requirements for improving R&D productivity and thereby increasing the number of drugs entering late phase trials [1,2]. Early characterisation of mechanism of action and pharmacodynamics (PD)-pharmacokinetic (PK) relationship in human disease before Phase 1 clinical trials would allow for more effective ‘triaging’ of preclinical candidates for entry into clinical development. Phase 0 studies, so named because they are positioned between pre-clinical and phase I stages, have no therapeutic intent and are not designed to study drug safety or tolerance, but are aimed at providing preliminary information regarding target engagement, mechanism of action, PD and PK [3,4]. These studies support the use of first-in-human testing of new investigational agents at sub-therapeutic doses (100μg or less). Their merit is based on reduced manufacturing and pre-clinical toxicologic and regulatory requirements while still allowing demonstration of drug-target effects and assessment of PK-PD relationships [5]. Phase 0 studies are particularly useful when there is incomplete understanding of mechanistic and PK/PD data from pre-clinical models [6,7]. if pre-clinical data suggests a high toxicity potential [8]. or if there are poor animal models for a human illness in which case early phase human trials may be the most appropriate model[9]. These challenges are frequently seen in chronic lung diseases and phase 0 trials have been utilised for respiratory drug development [10]. Interstitial lung diseases (ILD) are a group of inflammatory and fibrotic lung diseases amongst which a significant subgroup, such as idiopathic pulmonary fibrosis (IPF) and progressive fibrotic ILD (PF-ILD) are associated with a high burden of morbidity and mortality and effective treatment represents an unmet need. Non-cystic fibrosis (CF) bronchiectasis is a chronic suppurative lung disease characterised by cough, sputum production and frequent infections. The cycle of infection and inflammation leads to progressive lung damage. There is currently no disease modifying treatment for non-CF bronchiectasis. Despite the heterogenous aetiology and clinical features of these diseases, there may be some unifying molecular mechanisms. Inflammasome activation in alveolar macrophages (AM) has been shown in patients with IPF and other ILDs and sarcoidosis [11,12]. A subset of patients with bronchiectasis have evidence of inflammasome activation with high IL-1β sputum levels, mucus dehydration and ciliary dysfunction and more severe disease [13]. The inflammasome is therefore a potential target in ILD and non-CF bronchiectasis. The Clinical Investigational Agent (CIA), ADS032 (formerly known as BT032), is a novel nod-like receptor protein (NLRP) 1 and 3 inhibitor that has a promising pre-clinical toxicity and efficacy profile but has not been tested in humans. The Micro Study is a phase 0, experimental medicine study which will gather feasibility and mechanistic data of direct intrapulmonary dosing of ADS032 in patients with interstitial lung disease and bronchiectasis. This study seeks to test the hypotheses that microdosed ADS032 can attenuate inflammasome activity in chronic lung disease.
Study design
This is a small, exploratory Phase 0 experimental medicine study and as such formal sample size calculations have not been performed. ADS032 or vehicle will be microdosed into the distal lung during a bronchoscopic procedure, ensuring administration in different distal lung locations. Samples will be taken from all patients prior to, during and after the procedure to determine the activity and distribution of ADS032.
Patient and Public Involvement
There was no patient or public involvement in the design, conduct or reporting of the Micro trial.
Target population
Patients with suspected or confirmed ILD or bronchiectasis requiring bronchoscopy for clinical indications including diagnosis and exclusion or qualification of infection.
Inclusion and exclusion criteria
Inclusion criteria:
Exclusion criteria:
· Pregnant or breastfeeding.
· Known hypersensitivity to ADS032.
· In the Investigator’s opinion, patient is unwilling or unable to undergo a bronchoscopy, laboratory tests or other study procedures.
· 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).
Endpoints
The primary endpoint will be changes of BAL concentrations of inflammasome-associated mediators IL-1β, TNF-α, LDH, ATP, IL-6 and IL-18A between ADS032 and vehicle areas of lung. The secondary endpoint will be to determine pharmacokinetic (PK) data for the microdosed drug in blood. Exploratory endpoints will include the evaluation of a range of potential inflammasome mediators in lung samples and urine/respiratory sample PK.
Dosing regime
Bronchoscopy will be performed as per local clinical guidelines which include conscious sedation and topical, locally delivered anaesthetic. Up to 100μg of ADS032 (approximately 1.5 mL) will be delivered into the distal lung using a medically approved catheter. This can be administered as a single dose or smaller divided doses. The target area/s will be identified on chest X-ray (CXR)/ computerised tomography (CT) scan prior to the bronchoscopy and then aspirated using a medically approved catheter. Patients will serve as their own controls as an equivalent volume of 0.9% sodium chloride saline (vehicle) will be delivered to an area/s of diseased lung that has not been dosed with ADS032 and aspirated using a medically approved catheter. Medically approved devices will be used to perform the bronchoscopic sampling techniques bronchoalveolar lavage (BAL), micro-alveolar lavage (MAL) and distal airways brushings. Both BAL and distal airway brushings are commonly described procedures 14,15. BAL will deploy 1x40ml instilled aliquots and MAL will deploy 1-2mL instilled aliquots pre- and post- drug/vehicle delivery.
Sample processing and analyses
Briefly BAL samples with be centrifuged to separate the cellular fraction. BAL distal epithelial cells will be analysed by morphology and multiparameter flow cytometry utilising lineage markers to determine phenotype. Flow cytometry and analysis of early cytokine responses with ELISA and multi-plex platform will be performed along with bulk and single cell (sc)RNA-seq to investigate cellular activity in response to ADS032. BAL cells will be cultured and treated with inflammasome activators including LPS and assayed for transcriptional and cellular and secreted mediator expression. Cell lysates, BAL and MAL fluid, plasma and urine will be assayed for ADS032 concentrations with a validated LC-MS.
Sample size calculation
This is an early-stage feasibility and experimental medicine study and as such the sample size has been based upon the number of participants we can expect within the time frame and a cohort size intended to provide preliminary information for future studies. The number of participants (n=12) is in line with successfully completed Phase 0 trials in NHS Lothian with other microdosed compounds.
Descriptive statistics will be used to evaluate three aspects of ADS032:
· Change in inflammasome-associated biomarkers between pre- and post ADS032 or vehicle in respiratory samples.
· Quantification of ADS032 in blood, urine and respiratory samples using liquid chromatography-mass spectrometry (LC-MS).
· Change in exploratory biomarkers between pre- and post ADS032 or vehicle in respiratory samples.
All data will be listed, tabulated and/or presented graphically as suitable to the dataset and objective. Where appropriate summary statistics may be complemented with statistical tests and confidence intervals to aid in interpretation of magnitudes of effect and the likelihood of results occurring by chance.
For target pathway engagement, PK and exploratory biomarkers the estimand of interest is that which gives the most unbiased estimate of the impact of ADS032. As such all data will be included unless specific data points can a priori be identified as having potential to bias results in which case they will be excluded. An intent-to-treat approach will be taken to safety reporting, such that all subjects enrolled will be included.
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Dr Hala Al Shaikh This is to acknowledge that the peer review process for the article ’ A Novel Gnrh1 Gene Mutation in Four Omani Male Siblings, Presentation and Management ’ sent to the International Journal of Clinical Case Reports and Reviews was quick and smooth. The editorial office was prompt with easy communication.
Dear Erin Aust, Editorial Coordinator, Journal of General Medicine and Clinical Practice. We are pleased to share our experience with the “Journal of General Medicine and Clinical Practice”, following the successful publication of our article. The peer review process was thorough and constructive, helping to improve the clarity and quality of the manuscript. We are especially thankful to Ms. Erin Aust, the Editorial Coordinator, for her prompt communication and continuous support throughout the process. Her professionalism ensured a smooth and efficient publication experience. The journal upholds high editorial standards, and we highly recommend it to fellow researchers seeking a credible platform for their work. Best wishes By, Dr. Rakhi Mishra.
Dear Jessica Magne, Editorial Coordinator, Clinical Cardiology and Cardiovascular Interventions, Auctores Publishing LLC. The peer review process of the journal of Clinical Cardiology and Cardiovascular Interventions was excellent and fast, as was the support of the editorial office and the quality of the journal. Kind regards Walter F. Riesen Prof. Dr. Dr. h.c. Walter F. Riesen.
Dear Ashley Rosa, Editorial Coordinator, International Journal of Clinical Case Reports and Reviews, Auctores Publishing LLC. Thank you for publishing our article, Exploring Clozapine's Efficacy in Managing Aggression: A Multiple Single-Case Study in Forensic Psychiatry in the international journal of clinical case reports and reviews. We found the peer review process very professional and efficient. The comments were constructive, and the whole process was efficient. On behalf of the co-authors, I would like to thank you for publishing this article. With regards, Dr. Jelle R. Lettinga.
Dear Clarissa Eric, Editorial Coordinator, Journal of Clinical Case Reports and Studies, I would like to express my deep admiration for the exceptional professionalism demonstrated by your journal. I am thoroughly impressed by the speed of the editorial process, the substantive and insightful reviews, and the meticulous preparation of the manuscript for publication. Additionally, I greatly appreciate the courteous and immediate responses from your editorial office to all my inquiries. Best Regards, Dariusz Ziora
Dear Chrystine Mejia, Editorial Coordinator, Journal of Neurodegeneration and Neurorehabilitation, Auctores Publishing LLC, We would like to thank the editorial team for the smooth and high-quality communication leading up to the publication of our article in the Journal of Neurodegeneration and Neurorehabilitation. The reviewers have extensive knowledge in the field, and their relevant questions helped to add value to our publication. Kind regards, Dr. Ravi Shrivastava.
Dear Clarissa Eric, Editorial Coordinator, Journal of Clinical Case Reports and Studies, Auctores Publishing LLC, USA Office: +1-(302)-520-2644. I would like to express my sincere appreciation for the efficient and professional handling of my case report by the ‘Journal of Clinical Case Reports and Studies’. The peer review process was not only fast but also highly constructive—the reviewers’ comments were clear, relevant, and greatly helped me improve the quality and clarity of my manuscript. I also received excellent support from the editorial office throughout the process. Communication was smooth and timely, and I felt well guided at every stage, from submission to publication. The overall quality and rigor of the journal are truly commendable. I am pleased to have published my work with Journal of Clinical Case Reports and Studies, and I look forward to future opportunities for collaboration. Sincerely, Aline Tollet, UCLouvain.
Dear Ms. Mayra Duenas, Editorial Coordinator, International Journal of Clinical Case Reports and Reviews. “The International Journal of Clinical Case Reports and Reviews represented the “ideal house” to share with the research community a first experience with the use of the Simeox device for speech rehabilitation. High scientific reputation and attractive website communication were first determinants for the selection of this Journal, and the following submission process exceeded expectations: fast but highly professional peer review, great support by the editorial office, elegant graphic layout. Exactly what a dynamic research team - also composed by allied professionals - needs!" From, Chiara Beccaluva, PT - Italy.
Dear Maria Emerson, Editorial Coordinator, we have deeply appreciated the professionalism demonstrated by the International Journal of Clinical Case Reports and Reviews. The reviewers have extensive knowledge of our field and have been very efficient and fast in supporting the process. I am really looking forward to further collaboration. Thanks. Best regards, Dr. Claudio Ligresti
Dear Chrystine Mejia, Editorial Coordinator, Journal of Neurodegeneration and Neurorehabilitation. “The peer review process was efficient and constructive, and the editorial office provided excellent communication and support throughout. The journal ensures scientific rigor and high editorial standards, while also offering a smooth and timely publication process. We sincerely appreciate the work of the editorial team in facilitating the dissemination of innovative approaches such as the Bonori Method.” Best regards, Dr. Matteo Bonori.
I recommend without hesitation submitting relevant papers on medical decision making to the International Journal of Clinical Case Reports and Reviews. I am very grateful to the editorial staff. Maria Emerson was a pleasure to communicate with. The time from submission to publication was an extremely short 3 weeks. The editorial staff submitted the paper to three reviewers. Two of the reviewers commented positively on the value of publishing the paper. The editorial staff quickly recognized the third reviewer’s comments as an unjust attempt to reject the paper. I revised the paper as recommended by the first two reviewers.
Dear Maria Emerson, Editorial Coordinator, Journal of Clinical Research and Reports. Thank you for publishing our case report: "Clinical Case of Effective Fetal Stem Cells Treatment in a Patient with Autism Spectrum Disorder" within the "Journal of Clinical Research and Reports" being submitted by the team of EmCell doctors from Kyiv, Ukraine. We much appreciate a professional and transparent peer-review process from Auctores. All research Doctors are so grateful to your Editorial Office and Auctores Publishing support! I amiably wish our article publication maintained a top quality of your International Scientific Journal. My best wishes for a prosperity of the Journal of Clinical Research and Reports. Hope our scientific relationship and cooperation will remain long lasting. Thank you very much indeed. Kind regards, Dr. Andriy Sinelnyk Cell Therapy Center EmCell
Dear Editorial Team, Clinical Cardiology and Cardiovascular Interventions. It was truly a rewarding experience to work with the journal “Clinical Cardiology and Cardiovascular Interventions”. The peer review process was insightful and encouraging, helping us refine our work to a higher standard. The editorial office offered exceptional support with prompt and thoughtful communication. I highly value the journal’s role in promoting scientific advancement and am honored to be part of it. Best regards, Meng-Jou Lee, MD, Department of Anesthesiology, National Taiwan University Hospital.
Dear Editorial Team, Journal-Clinical Cardiology and Cardiovascular Interventions, “Publishing my article with Clinical Cardiology and Cardiovascular Interventions has been a highly positive experience. The peer-review process was rigorous yet supportive, offering valuable feedback that strengthened my work. The editorial team demonstrated exceptional professionalism, prompt communication, and a genuine commitment to maintaining the highest scientific standards. I am very pleased with the publication quality and proud to be associated with such a reputable journal.” Warm regards, Dr. Mahmoud Kamal Moustafa Ahmed
Dear Maria Emerson, Editorial Coordinator of ‘International Journal of Clinical Case Reports and Reviews’, I appreciate the opportunity to publish my article with your journal. The editorial office provided clear communication during the submission and review process, and I found the overall experience professional and constructive. Best regards, Elena Salvatore.
Dear Mayra Duenas, Editorial Coordinator of ‘International Journal of Clinical Case Reports and Reviews Herewith I confirm an optimal peer review process and a great support of the editorial office of the present journal
Dear Editorial Team, Clinical Cardiology and Cardiovascular Interventions. I am really grateful for the peers review; their feedback gave me the opportunity to reflect on the message and impact of my work and to ameliorate the article. The editors did a great job in addition by encouraging me to continue with the process of publishing.
Dear Cecilia Lilly, Editorial Coordinator, Endocrinology and Disorders, Thank you so much for your quick response regarding reviewing and all process till publishing our manuscript entitled: Prevalence of Pre-Diabetes and its Associated Risk Factors Among Nile College Students, Sudan. Best regards, Dr Mamoun Magzoub.
