Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT06677918
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Investigating the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults
Sponsor:
EpiEndo Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomised, Double-blind, Placebo-controlled Trial to Assess the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: