Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects

Summary

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF6523 DPI in healthy male subjects first and then in COPD subjects after single or repeated dosesof CHF6523. As an exploratory assessment, the anti-inflammatory effect of CHF6523 in COPDsubjects will be evaluated.

Timeline

Start

2019-07-24

Primary completion

2022-12-05

Completion

2022-12-05

Publications

• Govoni M, Bassi M, Girardello L, Lucci G, Rony F, Charretier R, Galkin D, Faietti ML, Pioselli B, Modafferi G, Benfeitas R, Bonatti M, Miglietta D, Clark J, Pedersen F, Kirsten AM, Beeh KM, Kornmann O, Korn S, Ludwig-Sengpiel A, Watz H. CHF6523 data suggest that the phosphoinositide 3-kinase delta isoform is not a suitable target for the management of COPD. Respir Res. 2024 Oct 19;25(1):380. doi: 10.1186/s12931-024-02999-5.

Drugs

Indications