Clinical Trial Comparing the Pharmacological Effects of EP395 With Placebo in Healthy Adults

Summary

This study aims to assess the effect of EP395 against an induced inflammation of the lung. In addition, further data about the safety and tolerability of EP395 will be collected. To investigate the efficacy of EP395 at the end of the treatment with EP395 or placebo (dummy), all participants will inhale a lipopolysaccharide (a molecule composed of sugar and fat) that artificially induces an acute inflammation of the airways. It is assumed that participants who received EP395 will show less inflammation of the airways than participants who received placebo.

Timeline

Start

2022-10-11

Primary completion

2023-06-21

Completion

2023-06-21

Outcome

Missed primary endpoint

release “For full study information, see ClinicalTrials.gov (NCT05516316). Although the primary endpoint (a statistically significant effect on IL-8) was not met” epiendo.com ↗

Publications

• Results Hohlfeld JM, Badorrek P, Breuer O, Hanrott K, Kricker J, Parnham MJ, Norris V. Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial. Pulm Pharmacol Ther. 2025 Sep;90:102365. doi: 10.1016/j.pupt.2025.102365. Epub 2025 Jun 3.

Drugs

Indications