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

NCT06677918 | Completed Phase 1

• 3 other identifiers: EP395-0062024-516187-29-00U1111-1310-4490
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Blood surfactant protein-D (SP-D)

  Change from baseline (pre-LPS) in blood SP-D on Day 21.

  Day 21

Secondary Outcomes (11)

• Blood biomarkers of immune response and systemic inflammation

  Day 21

• Lung inflammatory markers in exhaled particles (PEx)

  Day 21

• Plasma levels of EP395

  Day 1, 7, 13, 21 and 22

• Assessment of adverse event (AE) occurrence

  Day 1 to Day 37

• Electrocardiogram (ECG) recording

  Screening, Day 1, 7, 13, 21, 22 and 37

Study Arms (2)

EP395

EXPERIMENTAL

EP395 repeated doses (oral administration). Cohort A: daily (1 capsule) for 21 days. Cohort B (optional): every other day (1 capsule) for 21 days

Drug: EP395

Placebo

PLACEBO COMPARATOR

Matched placebo capsule (oral administration). Cohort A: daily (1 capsule) for 21 days. Cohort B (optional): every other day (1 capsule) for 21 days

Drug: Placebo

Interventions

EP395 DRUG

Capsule for oral use

EP395

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 qualify if:

• Willing and able to understand the requirements and restrictions of the study, and to provide voluntary, written informed consent.
• Aged ≥18 and ≤55 years at the time of signing the consent form.
• Body mass index (BMI) of ≥19.0 and ≤31.0 kg/m\^2 at Screening.
• Medically healthy without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of Screening, as judged by the investigator.
• Non-smoker, or former smoker with less than 10 pack years who stopped smoking (including e-cigarettes) at least 6 months before Screening.
• Normal pulmonary function test (spirometry) adjusted for sex, height, and age.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening (blood) and Day 1 (urine) and must agree to use, highly effective measures of contraceptive control during trial participation and until 90 days after the last intake of study drug.
• Women defined as of non-childbearing potential are postmenopausal (no menses for at least 1 year without alternative medical cause or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy).
• Men must agree to use a condom during sexual intercourse with WOCBP during treatment and for 90 days after the last IMP intake and should not donate sperm during this time.

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, or influence the results, or the participant's ability to participate in the trial.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
• Recent infection, including but not limited to SARS-CoV-2, within 14 days prior to the sputum screening collection or Day 1.
• Presence or history of lung disease, e.g., asthma or COPD.
• History of or active tuberculosis at the time of Screening based on participant anamnesis. Participants who have been living together with another person with active tuberculosis at any time over the past 10 years will also be excluded.
• Clinically significant abnormality on 12-lead ECG at Screening or Day 1 pre-dose.
• Abnormal renal function at Screening.
• Elevated liver values of Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 1.5 x upper limit of normal at Screening.
• Use of prescription or non-prescription medications or herbal remedies within 28 days prior to Day 1, or unable to refrain from prescription or non-prescription medications or herbal remedies during the trial, with the exception of hormone replacement therapy, contraception and occasional use of paracetamol.
• Live vaccine within 28 days or any other vaccine within 14 days prior to Day 1 until 28 days after the final dose.
• Any positive result at Screening for serum hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
• Positive drugs of abuse, smoking, or alcohol test at Screening or Day 1.
• History of alcohol abuse or excessive intake of alcohol, as judged by the investigator.
• Presence or history of drug abuse, as judged by the investigator.
• Pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.

Sponsors & Collaborators

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

Study Sites (1)

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Division of Clinical Airway Research

Hanover, 30625, Germany

Location

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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: February 20, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)