NCT06677918

Clinical Trial Investigating the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults

A Randomised, Double-blind, Placebo-controlled Trial to Assess the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: EpiEndo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical trial is to assess the effect of EP395 in a model of lung inflammation (inhaled lipopolysaccharide, which causes temporary inflammation in the airways). In addition, further information on the safety and tolerability of EP395 will be collected.

Detailed description

This is a randomized, double-blind, placebo-controlled trial in healthy adults. The study will assess the effect of repeated doses of EP395 on blood and lung markers of inflammation after inhaled lipopolysaccharide (LPS). It will also assess the safety, tolerability and systemic exposure of EP395. Participants will be randomized to receive EP395 or placebo (taken orally) for 21 days. On Day 21, participants will inhale LPS to induce airway inflammation. Blood and sputum (phlegm) samples will be taken before and after the LPS challenge to measure inflammatory markers. A final safety follow-up visit will be performed on Day 37. Depending on the results from the first cohort of participants (Cohort A), a second cohort may be recruited to test a lower dose of EP395 (Cohort B).

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	EP395	Capsule for oral use
DRUG	Placebo	Capsule for oral use

Timeline

• Start date: 2025-02-20
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2024-11-07
• Last updated: 2025-11-20

Locations

1 site across 1 country: Germany