New COPD drug candidate shows promise in early trial
NCT ID NCT05516316
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 Hide 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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