CompletedPhase 1

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

Germany49 participantsStarted 2022-10-11

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Bronchoalveolar lavage fluid interleukin 8 at Day 21

Timeframe: Day 21

Trial details

NCT IDNCT05516316

SponsorEpiEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-21

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