Trial reportBritish journal of clinical pharmacology2026
AZD0449, an inhaled JAK1 inhibitor, in healthy participants and patients with mild asthma.
Trial report in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03766399 (A Single-blind, Randomized, Placebo-Controlled 3-Part Study in Healthy Volunteers and Patients With Mild Asthma to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled AZD0449 Following Single and Multiple Ascending Doses and to Investigate the Anti-Inflammatory Effect of Inhaled AZD0449), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Single-blind, Randomized, Placebo-Controlled 3-Part Study in Healthy Volunteers and Patients With Mild Asthma to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled AZD0449 Following Single and Multiple Ascending Doses and to Investigate the Anti-Inflammatory Effect of Inhaled AZD0449
Who cites it
5 citing papers in PubMed.
- AZD0449, an inhaled JAK1 inhibitor, in healthy participants and patients with mild asthma.British journal of clinical pharmacology · 2026Trial
- Breaking the bottleneck of asthma treatment: the future of omni-targeted therapy.Journal of advanced research · 2026Review
- Emerging immune networks and targeted strategies in T2 asthma.Frontiers in immunology · 2026Review
- Integrated airway epithelial signaling networks linking allergen-driven inflammation to airway remodeling in asthma.Frontiers in immunology · 2026Review
- Inflammation and Immune Dysregulation Across Respiratory Diseases: From Cellular Mechanisms to Therapeutic Targets.Journal of inflammation research · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
aimsInhaled corticosteroids (ICS) plus bronchodilator are recommended for the treatment of asthma. Targeting the JAK1-dependent pathway may be an alternative for asthma management in patients with incomplete response to ICS. The aim of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD0449, a novel JAK1 selective inhibitor, following inhaled (dry powder, nebulized) and intravenous administration to healthy participants and patients with mild asthma.
methodsThis was a randomized, single-blind, placebo-controlled Phase 1 study (NCT03766399) of single- and multiple-ascending doses conducted using a three-part design. Healthy participants and patients with mild asthma aged 18-55 years were recruited. The study evaluated safety, tolerability, PK and PD of AZD0449. PD was measured as the effect on fractional exhaled nitric oxide (FeNO). Systemic target engagement was measured using phosphorylation of signal transducer and activator of transcription 6 (pSTAT6).
resultsA total of 125 participants were included in the study. No drug-related safety concerns emerged. Following inhaled administration, AZD0449 showed low, dose-proportional, systemic exposures and elimination from plasma was partly absorption-limited, suggesting lung retention and supporting once-daily dosing. At the dose levels evaluated (1.2-5.0 mg), there was no significant anti-inflammatory effect (reduction in FeNO) with AZD0449 vs. placebo, following repeated dosing for 14 days. Furthermore, there was no significant suppression of pSTAT6.
conclusionsAZD0449 was safely administered via inhalation, with low systemic exposure and lung retention. This study provides a greater understanding of inhaled dosing of small molecule JAK1 inhibitors for the treatment of asthma. No effect on PD biomarkers (FeNO and STAT6) was observed.
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