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

NCT ID: NCT05516316

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-06-21

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.

Detailed Description

This is a study to assess the pharmacological effect of repeated doses of EP395 in healthy subjects with the aim to assess the effects of EP395 on lung and blood markers of inflammation after inhaled lipopolysaccharide (LPS), and the safety, tolerability, and systemic exposure of EP395.

The study will be randomised in a 1:1 ratio to take either high dose EP395 or placebo as oral capsules once daily for 21 days starting on Day 1 with scheduled visits at Days 7, 14, and 21 for assessments of safety and tolerability and systemic exposure of EP395. At Day 21, 2 hours after the last investigational product (IP) intake, participants will undergo an inhaled LPS challenge to induce airway inflammation, which will be followed by bronchoscopy and BAL 6 hours later. A final safety follow-up visit will be performed at Day 37.

If the data from the high dose EP395 arm (variability, effect size) indicate that it may be possible to detect effects on IL-8 at a lower dose of EP395, an additional lower dose EP395 arm will be added.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EP395 high dose

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

Group Type: EXPERIMENTAL

EP395

Intervention Type: DRUG

Capsule for oral use

EP395 low dose

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

Group Type: EXPERIMENTAL

EP395

Intervention Type: DRUG

Capsule for oral use

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule for oral use

Interventions

EP395

Capsule for oral use

Intervention Type: DRUG

Placebo

Capsule for oral use

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. History or presence of any clinically relevant medical condition that could affect the participant's safety or interfere with the objectives of the study

2. Presence or history of lung disease, eg, asthma, chronic obstructive pulmonary disease

3. Clinically significant abnormality on 12-lead ECG including prolonged corrected QT interval by Fredericia (>450 msec men or >470 msec women)

4. Use of prescribed or nonprescribed medications or herbal remedies within 28 days of first dosing and during the study with the exception of

1. hormone replacement therapy (HRT)

2. contraception

3. occasional use of paracetamol

5. Positive hepatitis B surface antigen, hepatitis C antibodies, HIV-1 or -2 antibodies

6. Positive drugs of abuse, smoking, or alcohol test at Screening

7. History of alcohol or drug misuse

8. Pregnant and lactating women

9. Prior recovery from recent infection, including but not limited to COVID-19, within the last 14 days before first dosing with IP

10. History of hypersensitivity to any constituents of the IMP or LPS

11. Any clinically significant allergy

12. Participation in a clinical study with an IP within 3 months or 5 half-lives before first dosing, whichever is longer

13. Employees of the sponsor or employees or relatives of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FGK Clinical Research GmbH

INDUSTRY

Sponsor Role: collaborator

EpiEndo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Hohlfeld, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Locations

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Hanover, , Germany

Countries

Germany

Other Identifiers

2021-005867-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP395-002

Identifier Type: -

Identifier Source: org_study_id