Investigating the effects of EP395 on lung inflammation in healthy adults

A Randomised, Double-blind, Placebo-controlled Trial to Assess the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults

This study is testing if a new drug called EP395 can help reduce lung inflammation caused by inhaling a substance in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: EpiEndo Pharmaceuticals (Industry-sponsored)
• Locations: 1 site (Hanover)
• Trial ID: NCT06677918 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of EP395 on lung inflammation induced by inhaled lipopolysaccharide (LPS) in healthy adults. It is a randomized, double-blind, placebo-controlled study where participants will receive either EP395 or a placebo for 21 days. On Day 21, participants will inhale LPS to provoke temporary airway inflammation, and various blood and sputum samples will be collected to assess inflammatory markers. The study will also monitor the safety and tolerability of EP395 throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a normal BMI and no significant medical history.

Not a fit: Patients with chronic respiratory conditions or significant medical histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments for managing lung inflammation.

How similar studies have performed: Other studies have shown promise in using similar approaches to assess lung inflammation, but this specific intervention is novel.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to understand the requirements and restrictions of the study, and to provide voluntary, written informed consent.
2. Aged ≥18 and ≤55 years at the time of signing the consent form.
3. Body mass index (BMI) of ≥19.0 and ≤31.0 kg/m\^2 at Screening.
4. 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.
5. Non-smoker, or former smoker with less than 10 pack years who stopped smoking (including e-cigarettes) at least 6 months before Screening.
6. Normal pulmonary function test (spirometry) adjusted for sex, height, and age.
7. 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.

Exclusion Criteria:

1. 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.
2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
3. Recent infection, including but not limited to SARS-CoV-2, within 14 days prior to the sputum screening collection or Day 1.
4. Presence or history of lung disease, e.g., asthma or COPD.
5. 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.
6. Clinically significant abnormality on 12-lead ECG at Screening or Day 1 pre-dose.
7. Abnormal renal function at Screening.
8. Elevated liver values of Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 1.5 x upper limit of normal at Screening.
9. 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.
10. Live vaccine within 28 days or any other vaccine within 14 days prior to Day 1 until 28 days after the final dose.
11. Any positive result at Screening for serum hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
12. Positive drugs of abuse, smoking, or alcohol test at Screening or Day 1.
13. History of alcohol abuse or excessive intake of alcohol, as judged by the investigator.
14. Presence or history of drug abuse, as judged by the investigator.
15. Pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
16. Known hypersensitivity to LPS, macrolides or EP395 or any of the study products.
17. Any clinically significant allergy, as judged by the investigator.
18. Planned treatment or treatment with another investigational drug within 5 half-lives or 3 months before the first administration of study drug, whichever is longer. Participants consented and screened, but not dosed in a previous clinical trial are not excluded.
19. Blood donation (or corresponding blood loss) greater than 400 mL, during the 3 months before the first administration of study drug.
20. Employees of the sponsor or employees or relatives of the investigator.
21. The investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
22. Withdrawal of consent before randomisation (despite meeting the other eligibility criteria).

Where this trial is running

Hanover

• Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Division of Clinical Airway Research — Hanover, Germany (Recruiting)

Study contacts

• Study coordinator: EpiEndo Clinical Trials Information

Conditions Healthy Volunteer