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

NCT05516316 | Completed Phase 1

• 2 other identifiers: EP395-0022021-005867-28
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

COPD; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Bronchoalveolar lavage fluid interleukin 8 at Day 21

  Day 21

Secondary Outcomes (20)

• ECG ventricular rate

  Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)

• ECG RR interval

  Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)

• ECG PR interval

  Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)

• ECG QRS duration

  Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)

• ECG QT interval (uncorrected)

  Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)

Study Arms (3)

EP395 high dose

EXPERIMENTAL

EP395 in repeated doses. Orally, once-daily administration of 3 EP395 capsules for 21 days

Drug: EP395

EP395 low dose

EXPERIMENTAL

EP395 in repeated doses. Orally, once-daily administration of 1 EP395 capsule and 2 placebo capsules for 21 days

Drug: EP395

Placebo

PLACEBO COMPARATOR

Matched placebo capsule, once-daily administration of 3 placebo capsules for 21 days

Drug: Placebo

Interventions

EP395 DRUG

Capsule for oral use

EP395 high dose; EP395 low dose

Placebo DRUG

Capsule for oral use

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• History or presence of any clinically relevant medical condition that could affect the participant's safety or interfere with the objectives of the study
• Presence or history of lung disease, eg, asthma, chronic obstructive pulmonary disease
• Clinically significant abnormality on 12-lead ECG including prolonged corrected QT interval by Fredericia (\>450 msec men or \>470 msec women)
• Use of prescribed or nonprescribed medications or herbal remedies within 28 days of first dosing and during the study with the exception of
• hormone replacement therapy (HRT)
• contraception
• occasional use of paracetamol
• Positive hepatitis B surface antigen, hepatitis C antibodies, HIV-1 or -2 antibodies
• Positive drugs of abuse, smoking, or alcohol test at Screening
• History of alcohol or drug misuse
• Pregnant and lactating women
• Prior recovery from recent infection, including but not limited to COVID-19, within the last 14 days before first dosing with IP
• History of hypersensitivity to any constituents of the IMP or LPS
• Any clinically significant allergy
• Participation in a clinical study with an IP within 3 months or 5 half-lives before first dosing, whichever is longer

Sponsors & Collaborators

• EpiEndo Pharmaceuticals: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (1)

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Hanover, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 40466859 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Hohlfeld, Prof. Dr.

  Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: During the study, study participants, investigators, the sponsor, and all other persons involved in the conduct of the study will be blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is double-blind, placebo-controlled and parallel-group in design.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 25, 2022
• Study Start: October 11, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)