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

NCT05516316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

EP395

Capsule for oral use

DRUG

Placebo

Capsule for oral use

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • EpiEndo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jens Hohlfeld, Prof. Dr. · Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2023-06-21
Completion
2023-06-21

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516316 on ClinicalTrials.gov