Chronic Obstructive Pulmonary DiseasePhase 1NCT05516316
Clinical Trial Comparing the Pharmacological Effects of EP395 With Placebo in Healthy Adults
A Phase 1 study testing EP395 in people with Chronic Obstructive Pulmonary Disease and COPD, run by EpiEndo Pharmaceuticals at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- 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
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 11 Oct 2022to 21 Jun 2023
- 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
None listed.
Who cannot join
- 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
Show all 16Show fewer
- occasional use of paracetamol
- Positive hepatitis B surface antigen, hepatitis C antibodies, HIV-1 or -2 antibodies
- Positive drugs of abuse, smoking, or alcohol test at Screening
- History of alcohol or drug misuse
- Pregnant and lactating women
- Prior recovery from recent infection, including but not limited to COVID-19, within the last 14 days before first dosing with IP
- History of hypersensitivity to any constituents of the IMP or LPS
- Any clinically significant allergy
- Participation in a clinical study with an IP within 3 months or 5 half-lives before first dosing, whichever is longer
- Employees of the sponsor or employees or relatives of the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Hanover, 30625
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Proof-of-pharmacology Study of EP395 in Healthy Adults
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.
Read the detailed description
This is a study to assess the pharmacological effect of repeated doses of EP395 in healthy subjects with the aim to assess the effects of EP395 on lung and blood markers of inflammation after inhaled lipopolysaccharide (LPS), and the safety, tolerability, and systemic exposure of EP395.
The study will be randomised in a 1:1 ratio to take either high dose EP395 or placebo as oral capsules once daily for 21 days starting on Day 1 with scheduled visits at Days 7, 14, and 21 for assessments of safety and tolerability and systemic exposure of EP395. At Day 21, 2 hours after the last investigational product (IP) intake, participants will undergo an inhaled LPS challenge to induce airway inflammation, which will be followed by bronchoscopy and BAL 6 hours later. A final safety follow-up visit will be performed at Day 37.
If the data from the high dose EP395 arm (variability, effect size) indicate that it may be possible to detect effects on IL-8 at a lower dose of EP395, an additional lower dose EP395 arm will be added.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- EP395, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 high dose | Experimental | EP395 in repeated doses. Orally, once-daily administration of 3 EP395 capsules for 21 days Receives: Drug: EP395 |
| EP395 low dose | Experimental | EP395 in repeated doses. Orally, once-daily administration of 1 EP395 capsule and 2 placebo capsules for 21 days Receives: Drug: EP395 |
| Placebo | Placebo comparator | Matched placebo capsule, once-daily administration of 3 placebo capsules for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoalveolar lavage fluid interleukin 8 at Day 21
Measured: Day 21
Secondary outcomes (20)
ECG ventricular rate
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG RR interval
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG PR interval
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG QRS duration
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG QT interval (uncorrected)
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG QTcF intervals
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Assessment of laboratory values (haematology)
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Assessment of laboratory values (blood biochemistry)
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Assessment of blood coagulation
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Urinalysis
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Vital signs: Systolic and diastolic blood pressure
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days)
Vital signs: Pulse
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days)
Vital signs: Body temperature
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days)
Height and weight
BMI will be calculated from height and weight measurements
Measured: Screening (Day -21 to Day -1), Day 37 (±3 days)
Standard routine physical examination
A standard routine physical body examination will be performed and abnormal physical examination results will be evaluated and reported as AEs.
Measured: Screening (Day -21 to Day -1), Days 1, Day 21 (±2 days), Day 37 (±3 days)
Assessment of adverse event (AE) occurrence
Measured: From Screening (Day -21 to Day -1), to Day 37 (±3 days)
BALF cell count (total and differential) and mediators
Including tumour necrosis factor (TNF)-α, IL-6, IL-1β, macrophage inflammatory protein (MIP)-1α, MIP-1β, monocyte chemotactic protein-1, intercellular adhesion molecule-1, surfactant protein (SP)-D, granulocyte macrophage colony-stimulating factor, IL-23, IL-33, IL-25, IL-10, albumin, and protein
Measured: Day 21 (±2 days)
Exhaled particles IL-6 and IL-8
Measured: Day 21 (±2 days)
Blood inflammatory markers including C-reactive protein, TNF-α, IL-6, IL-8, and α2-macroglobulin
Measured: Day 21 (±2 days)
Plasma EP395
Measured: Day 7 (±2 days) [only applicable for trough levels of EP395], Day 14 (±2 days) and Day 21 (±2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start11 Oct 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is double-blind, placebo-controlled and parallel-group in design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpiEndo Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, Prof. Dr., Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516316
- Sponsor's protocol ID
- EP395-002
- Other IDs
- 2021-005867-28
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hohlfeld JM, Badorrek P, Breuer O, Hanrott K, Kricker J, Parnham MJ, Norris V. Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial. Pulm Pharmacol Ther. 2025 Sep;90:102365. doi: 10.1016/j.pupt.2025.102365. Epub 2025 Jun 3.
PubMed 40466859
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Proof-of-pharmacology Study of EP395 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05516316
- Acronym / sponsor ID
- EP395-002
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- EpiEndo PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 25 Aug 2022 (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.
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.
Detailed description
This is a study to assess the pharmacological effect of repeated doses of EP395 in healthy subjects with the aim to assess the effects of EP395 on lung and blood markers of inflammation after inhaled lipopolysaccharide (LPS), and the safety, tolerability, and systemic exposure of EP395.
The study will be randomised in a 1:1 ratio to take either high dose EP395 or placebo as oral capsules once daily for 21 days starting on Day 1 with scheduled visits at Days 7, 14, and 21 for assessments of safety and tolerability and systemic exposure of EP395. At Day 21, 2 hours after the last investigational product (IP) intake, participants will undergo an inhaled LPS challenge to induce airway inflammation, which will be followed by bronchoscopy and BAL 6 hours later. A final safety follow-up visit will be performed at Day 37.
If the data from the high dose EP395 arm (variability, effect size) indicate that it may be possible to detect effects on IL-8 at a lower dose of EP395, an additional lower dose EP395 arm will be added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study is double-blind, placebo-controlled and parallel-group in design.
| Arm | Type | Receives |
|---|---|---|
| EP395 high dose | Experimental | Drug: EP395EP395 in repeated doses. Orally, once-daily administration of 3 EP395 capsules for 21 days |
| EP395 low dose | Experimental | Drug: EP395EP395 in repeated doses. Orally, once-daily administration of 1 EP395 capsule and 2 placebo capsules for 21 days |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo capsule, once-daily administration of 3 placebo capsules for 21 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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
- Positive hepatitis B surface antigen, hepatitis C antibodies, HIV-1 or -2 antibodies
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 high dose, EP395 low dose |
| PlaceboCapsule for oral use | Drug | Placebo |
Primary outcome
Bronchoalveolar lavage fluid interleukin 8 at Day 21
Time frame: Day 21
20 secondary outcomes
ECG ventricular rate
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG RR interval
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG PR interval
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG QRS duration
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG QT interval (uncorrected)
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
ECG QTcF intervals
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Assessment of laboratory values (haematology)
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Assessment of laboratory values (blood biochemistry)
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Assessment of blood coagulation
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Urinalysis
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days), Day 37 (±3 days)
Vital signs: Systolic and diastolic blood pressure
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days)
Vital signs: Pulse
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days)
Vital signs: Body temperature
Time frame: Screening (Day -21 to Day -1), Days 1, 7 (±2 days), 14 (±2 days), Day 21 (±2 days)
Height and weight
Time frame: Screening (Day -21 to Day -1), Day 37 (±3 days)
Standard routine physical examination
Time frame: Screening (Day -21 to Day -1), Days 1, Day 21 (±2 days), Day 37 (±3 days)
Assessment of adverse event (AE) occurrence
Time frame: From Screening (Day -21 to Day -1), to Day 37 (±3 days)
BALF cell count (total and differential) and mediators
Time frame: Day 21 (±2 days)
Exhaled particles IL-6 and IL-8
Time frame: Day 21 (±2 days)
Blood inflammatory markers including C-reactive protein, TNF-α, IL-6, IL-8, and α2-macroglobulin
Time frame: Day 21 (±2 days)
Plasma EP395
Time frame: Day 7 (±2 days) [only applicable for trough levels of EP395], Day 14 (±2 days) and Day 21 (±2 days)
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 29 Apr 2026.
- Results publication: PubMed 40466859Hohlfeld JM, Badorrek P, Breuer O, Hanrott K, Kricker J, Parnham MJ, Norris V. Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial. Pulm Pharmacol Ther. 2025 Sep;90:102365. doi: 10.1016/j.pupt.2025.102365. Epub 2025 Jun 3.
- Individual participant dataSharing planned: No
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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.
Jens Hohlfeld, Prof. Dr. principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
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 Chronic Obstructive Pulmonary Disease and COPD, 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 0 inclusion and 16 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 29 Apr 2026. 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?
Bronchoalveolar lavage fluid interleukin 8 at Day 21 (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516316, which also lists 1 linked publication.
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 29 Apr 2026.