Healthy VolunteerPhase 1NCT06677918
Clinical Trial Investigating the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults
A Phase 1 study testing EP395 in people with Healthy Volunteer, run by EpiEndo Pharmaceuticals at 1 site in Germany.
Trial summary
The aim of this clinical trial is to assess the effect of EP395 in a model of lung inflammation (inhaled lipopolysaccharide, which causes temporary inflammation in the airways). In addition, further information on the safety and tolerability of EP395 will be collected. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- EP395
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2025to 25 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to understand the requirements and restrictions of the study, and to provide voluntary, written informed consent.
- Aged ≥18 and ≤55 years at the time of signing the consent form.
- Body mass index (BMI) of ≥19.0 and ≤31.0 kg/m^2 at Screening.
- 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.
- Non-smoker, or former smoker with less than 10 pack years who stopped smoking (including e-cigarettes) at least 6 months before Screening.
- Normal pulmonary function test (spirometry) adjusted for sex, height, and age.
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- 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.
Who cannot join
- 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.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
- Recent infection, including but not limited to SARS-CoV-2, within 14 days prior to the sputum screening collection or Day 1.
- Presence or history of lung disease, e.g., asthma or COPD.
- 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.
- Clinically significant abnormality on 12-lead ECG at Screening or Day 1 pre-dose.
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- Abnormal renal function at Screening.
- Elevated liver values of Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 1.5 x upper limit of normal at Screening.
- 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.
- Live vaccine within 28 days or any other vaccine within 14 days prior to Day 1 until 28 days after the final dose.
- Any positive result at Screening for serum hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Positive drugs of abuse, smoking, or alcohol test at Screening or Day 1.
- History of alcohol abuse or excessive intake of alcohol, as judged by the investigator.
- Presence or history of drug abuse, as judged by the investigator.
- Pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
- Known hypersensitivity to LPS, macrolides or EP395 or any of the study products.
- Any clinically significant allergy, as judged by the investigator.
- 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.
- Blood donation (or corresponding blood loss) greater than 400 mL, during the 3 months before the first administration of study drug.
- Employees of the sponsor or employees or relatives of the investigator.
- The investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
- Withdrawal of consent before randomisation (despite meeting the other eligibility criteria).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Division of Clinical Airway Research
Hanover, 30625
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults
The aim of this clinical trial is to assess the effect of EP395 in a model of lung inflammation (inhaled lipopolysaccharide, which causes temporary inflammation in the airways). In addition, further information on the safety and tolerability of EP395 will be collected.
Read the detailed description
This is a randomized, double-blind, placebo-controlled trial in healthy adults. The study will assess the effect of repeated doses of EP395 on blood and lung markers of inflammation after inhaled lipopolysaccharide (LPS). It will also assess the safety, tolerability and systemic exposure of EP395.
Participants will be randomized to receive EP395 or placebo (taken orally) for 21 days. On Day 21, participants will inhale LPS to induce airway inflammation. Blood and sputum (phlegm) samples will be taken before and after the LPS challenge to measure inflammatory markers. A final safety follow-up visit will be performed on Day 37.
Depending on the results from the first cohort of participants (Cohort A), a second cohort may be recruited to test a lower dose of EP395 (Cohort B).
- Conditions
- Healthy Volunteer
- Being tested
- EP395, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP395Drug
Capsule for oral use
PlaceboDrug
Capsule for oral use
| Study group | Role | What they receive |
|---|---|---|
| EP395 | Experimental | EP395 repeated doses (oral administration). Cohort A: daily (1 capsule) for 21 days. Cohort B (optional): every other day (1 capsule) for 21 days Receives: Drug: EP395 |
| Placebo | Placebo comparator | Matched placebo capsule (oral administration). Cohort A: daily (1 capsule) for 21 days. Cohort B (optional): every other day (1 capsule) for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood surfactant protein-D (SP-D)
Change from baseline (pre-LPS) in blood SP-D on Day 21.
Measured: Day 21
Secondary outcomes (11)
Blood biomarkers of immune response and systemic inflammation
Change from baseline (pre-LPS) in blood biomarkers on Day 21.
Measured: Day 21
Lung inflammatory markers in exhaled particles (PEx)
Change from baseline (pre-LPS) in PEx biomarkers on Day 21.
Measured: Day 21
Plasma levels of EP395
Measured: Day 1, 7, 13, 21 and 22
Assessment of adverse event (AE) occurrence
Measured: Day 1 to Day 37
Electrocardiogram (ECG) recording
12-lead ECG recording to determine ventricular rate, ECG heart rate, RR interval, PR interval, QRS duration, QT interval (uncorrected), and QT interval corrected by Fredericia's formula (QTcF).
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening, Day 1, 7, 13, 21, 22 and 37
Assessment of laboratory values (haematology)
Absolute values and changes from baseline will be summarized for all assessed time points .
Measured: Screening, Day 1, 7, 13, 21, and 37
Assessment of laboratory values (blood biochemistry)
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening, Day 1, 7, 13, 21, and 37
Vital signs - Heart rate
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening, Day 1, 7, 13, 21, and 37
Vital signs: Systolic and diastolic blood pressure
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening, Day 1, 7, 13, 21, and 37
Vital signs - Body temperature
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening, Day 1, 7, 13, 21, and 37
Physical Examination
Standard routine physical examination. Clinically significant changes will be reported as AEs.
Measured: Screening, Day 1, 13, 21, and 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start20 Feb 2025
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpiEndo Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677918
- Sponsor's protocol ID
- EP395-006
- Other IDs
- 2024-516187-29-00, U1111-1310-4490
- Status last verified
- Nov 2025
- First submitted
- 5 Nov 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial to Assess the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults
- ClinicalTrials.gov ID
- NCT06677918
- Acronym / sponsor ID
- EP395-006
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- EpiEndo PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to assess the effect of EP395 in a model of lung inflammation (inhaled lipopolysaccharide, which causes temporary inflammation in the airways). In addition, further information on the safety and tolerability of EP395 will be collected.
Detailed description
This is a randomized, double-blind, placebo-controlled trial in healthy adults. The study will assess the effect of repeated doses of EP395 on blood and lung markers of inflammation after inhaled lipopolysaccharide (LPS). It will also assess the safety, tolerability and systemic exposure of EP395.
Participants will be randomized to receive EP395 or placebo (taken orally) for 21 days. On Day 21, participants will inhale LPS to induce airway inflammation. Blood and sputum (phlegm) samples will be taken before and after the LPS challenge to measure inflammatory markers. A final safety follow-up visit will be performed on Day 37.
Depending on the results from the first cohort of participants (Cohort A), a second cohort may be recruited to test a lower dose of EP395 (Cohort B).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP395 | Experimental | Drug: EP395EP395 repeated doses (oral administration). Cohort A: daily (1 capsule) for 21 days. Cohort B (optional): every other day (1 capsule) for 21 days |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo capsule (oral administration). Cohort A: daily (1 capsule) for 21 days. Cohort B (optional): every other day (1 capsule) for 21 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willing and able to understand the requirements and restrictions of the study, and to provide voluntary, written informed consent.
- Aged ≥18 and ≤55 years at the time of signing the consent form.
- Body mass index (BMI) of ≥19.0 and ≤31.0 kg/m^2 at Screening.
- 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.
- Non-smoker, or former smoker with less than 10 pack years who stopped smoking (including e-cigarettes) at least 6 months before Screening.
Key exclusion criteria (22 listed)
- 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.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
- Recent infection, including but not limited to SARS-CoV-2, within 14 days prior to the sputum screening collection or Day 1.
- Presence or history of lung disease, e.g., asthma or COPD.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP395Capsule for oral use | Drug | EP395 |
| PlaceboCapsule for oral use | Drug | Placebo |
Primary outcome
Blood surfactant protein-D (SP-D)
Time frame: Day 21
Change from baseline (pre-LPS) in blood SP-D on Day 21.
11 secondary outcomes
Blood biomarkers of immune response and systemic inflammation
Time frame: Day 21
Lung inflammatory markers in exhaled particles (PEx)
Time frame: Day 21
Plasma levels of EP395
Time frame: Day 1, 7, 13, 21 and 22
Assessment of adverse event (AE) occurrence
Time frame: Day 1 to Day 37
Electrocardiogram (ECG) recording
Time frame: Screening, Day 1, 7, 13, 21, 22 and 37
Assessment of laboratory values (haematology)
Time frame: Screening, Day 1, 7, 13, 21, and 37
Assessment of laboratory values (blood biochemistry)
Time frame: Screening, Day 1, 7, 13, 21, and 37
Vital signs - Heart rate
Time frame: Screening, Day 1, 7, 13, 21, and 37
Vital signs: Systolic and diastolic blood pressure
Time frame: Screening, Day 1, 7, 13, 21, and 37
Vital signs - Body temperature
Time frame: Screening, Day 1, 7, 13, 21, and 37
Physical Examination
Time frame: Screening, Day 1, 13, 21, and 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EP395 in people with Healthy Volunteer, run by EpiEndo Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood surfactant protein-D (SP-D) (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.