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New COPD drug candidate shows promise in early trial

NCT ID NCT05516316

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested whether EP395, an oral capsule, can reduce lung inflammation in healthy adults. All 49 participants inhaled a substance that causes temporary airway inflammation, mimicking a key feature of COPD. Researchers measured inflammation levels and collected safety data to see if EP395 works better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EP395 (oral capsule)
What this could lead to
If it works, this could point toward a treatment that reduces lung inflammation in people with COPD.
What could go wrong
This is a very early Phase 1 trial in only 49 healthy adults, not COPD patients. The lung inflammation was artificially induced, so results may not translate to real-world COPD. The drug may also have side effects not yet seen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

49 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

    Hanover, 30625, Germany

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