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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: EpiEndo Pharmaceuticals
• Collaborator: FGK Clinical Research GmbH

Criteria

1. Willing and able to understand the information on the nature, the scope and the relevance of the clinical study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures

2. Men and women, aged ≥18 and ≤55 years

3. Women of childbearing potential must:

1. have a negative pregnancy test (blood) at Screening.

2. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, from Screening until 90 days after the last IP intake.

4. Men must agree to use contraception (barrier method) during sexual intercourse with women of childbearing potential during treatment until 90 days after the last IP intake and should not donate sperm during this time.

5. In good health as determined by medical history and screening investigations, as judged by the investigator

6. Body mass index of ≥19 and ≤33 kg/m2

7. Normal spirometry (forced expiratory volume in 1 second [FEV1] >80% predicted and FEV1/forced vital capacity >70%)

8. Non-smoker or former smoker with <10 pack years who had stopped smoking (including e-cigarettes) for at least 6 months before Screening.

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