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Adult ALLPhase 1NCT04819854

Single and Multiple Ascending Dose Study With EP395

A Phase 1 study testing EP395 in people with Adult ALL, run by EpiEndo Pharmaceuticals at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Adult ALL
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
78 participants
Where
1 siteUnited Kingdom
Study dates
5 Apr 2021to 22 Mar 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject's written informed consent obtained prior to any study-related procedures.
  • Able to understand and comply with the requirements of the study, as judged by the investigator or designee.
  • Men and women between 18-65 years inclusive
  • Female subjects must either be of non-childbearing potential or if of childbearing potential, must not be pregnant or breast feeding and use a highly effective birth control method during treatment and for 90 days following last dose
  • Male subjects must use highly effective contraception during treatment and for 90 days following last administered dose
  • Subject must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP
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  • Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
  • Subjects with normal hearing
  • Subjects must be in good health at the time of screening

Who cannot join

  • History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety.
  • History or presence of vestibular disorder including vertigo, dizziness or other auditory impairment as judged by the investigator or designee.
  • After 10 minutes supine rest at the time of screening or prior to dosing, any vital signs values outside the following ranges:
  • Systolic blood pressure <90 or >150 mmHg, or
  • Diastolic blood pressure <50 or >95 mmHg, or
  • Pulse <40 or >90 bpm
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  • Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (>450 ms for males; >470 ms for females) and cardiac arrhythmias, as judged by the Investigator or designee.
  • Clinically significant abnormalities in renal function:
  • serum creatinine >ULN
  • eGFR <60 mL/min or ≥ 60mL/min with evidence of any kidney dysfunction (e.g. proteinuria, or clinical findings as judged by the investigator)
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP (Day 1).
  • Malignancy within the past five years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
  • Any planned major surgery within the duration of the study.
  • History of latent or active tuberculosis or a positive Quantiferon test at screening.
  • Females who are pregnant, breast feeding or plan to be pregnant during the study period or 90 days after.
  • Female subjects with a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening and within 24 h prior to the first administration of IMP.
  • Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
  • Positive PCR test for active COVID -19 tested within seven days prior to administration of the IMP on Day 1.
  • History of any drug and/or alcohol abuse in the past two years prior to screening.
  • Regular alcohol consumption in males >21 units per week and females >14 units per week.
  • Positive urine drugs of abuse test and/or alcohol breath test at screening or on admission to the unit prior to administration of the IMP on Day -1 that cannot be accounted for by concomitant medication in the opinion of the Investigator or designee.
  • Current or previous use of tobacco, nicotine products or e-cigarettes in the past six months.
  • Smoking history of > 5 pack years.
  • Positive urine cotinine test at screening or Day -1.
  • Use of any prescribed or non-prescribed medication including analgesics, herbal remedies, vitamins and minerals within two weeks prior to the (first) administration of IMP, except those listed below, at the discretion of the Investigator or designee:
  • hormone replacement therapy (HRT)
  • hormonal contraception
  • occasional intake of paracetamol (maximum 2000 mg/day for 3 consecutive days)
  • nasal decongestants without cortisone for a maximum of 10 days
  • antihistamines for a maximum of 10 days
  • anticholinergics for a maximum of 10 days
  • Use of antacids, PPIs or any medication that changes gastric pH within two weeks prior to the first administration of IMP (Day 1).
  • Use of macrolide antibiotics within two weeks prior to the first administration of IMP (Day 1)
  • Subjects who have received a live vaccine in the 28 days prior to Day 1.
  • Plasma donation within one month of screening or blood donation (or corresponding blood loss) ≥400mL during the three months prior to screening.
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or designee at screen.
  • Subject has dietary restrictions incompatible with the diet that can be provided by the study site, in the opinion of the Investigator or is unwilling to refrain from consuming restricted foods and beverages during the study
  • Regular excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.
  • Known history of intolerance or hypersensitivity to macrolides, EP395 or to any other component of the formulation.
  • Known history of intolerance to lactose.
  • Clinically significant serious adverse reaction, allergy or serious hypersensitivity, including to any drug or food, as judged by the Investigator or designee.
  • Involvement in the planning and conduct of the study (applies to all EpiEndo, CRO or investigational site staff).
  • Participation in another clinical study with an experimental drug within three months or 5 half-lives, whichever is shorter, before the administration of IMP.
  • Considered unsuitable for entry into the study in any other way at the discretion of the principal investigator or designee, e.g. investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Medicines Evaluation Unit (MEU) Ltd.

    Manchester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A First-in Man, Phase I Study Investigating the Safety and Tolerability of EP395 in Healthy Volunteers

This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development

Read the detailed description

This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development. The study consists of two parts, part A where single-ascending doses will be assessed and part B where multiple-ascending doses will be assessed. The primary objective being safety and tolerability as well as the pharmacokinetic properties of EP395.

Conditions
Adult ALL
Being tested
EP395, Placebo
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EP395Drug

    capsule for oral treatment

  • PlaceboDrug

    capsule for oral treatment

Study groups in NCT04819854
Study groupRoleWhat they receive
EP395ExperimentalEP395 in ascending doses. Orally, once daily.
Receives: Drug: EP395
PlaceboPlacebo comparatorPlacebo, weight matched in ascending doses. Orally, once daily.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the safety of EP395

    Adverse Events

    Measured: from baseline to day 7 and day 42

  2. To assess the effect of EP395 on ECG

    QT intervals

    Measured: from baseline to day 7 and day 42

  3. To assess the effect of EP395 on temperature

    Temperature

    Measured: from baseline to day 7 and day 42

  4. To assess the effect of EP395 on blood pressure

    Blood pressure

    Measured: from baseline to day 7 and day 42

  5. To assess the effect of EP395 on pulse

    Pulse

    Measured: from baseline to day 7 and day 42

  6. To assess the effect of EP395 on hearing

    Audiometry

    Measured: from baseline to day 7 and day 42

Secondary outcomes (4)

  1. To assess the Cmax of EP395 in plasma and blood

    Maximum Plasma Concentration [Cmax]

    Measured: from baseline to day 7 and day 42

  2. To assess the tmax of EP395 in plasma and blood

    Time to reach Cmax (Tmax)

    Measured: from baseline to day 7 and day 42

  3. To assess the t½ of EP395 in plasma and blood

    Time to half-life (t½)

    Measured: from baseline to day 7 and day 42

  4. To assess the AUC of EP395 in plasma and blood

    Area Under the Curve (AUC)

    Measured: from baseline to day 7 and day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start5 Apr 2021
  3. Primary completion22 Mar 2022
  4. Study completion22 Mar 2022

Resources

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
Sequential
Model description
Single and multiple ascending doses
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819854
Sponsor's protocol ID
EP395-001
Status last verified
Apr 2026
First submitted
4 Mar 2021
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Singh D, Hanrott K, Breuer O, Bylund J, Schultze B, Norris V. Early clinical pharmacology evaluation of the novel anti-inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions. Br J Clin Pharmacol. 2026 Jul;92(7):2349-2363. doi: 10.1002/bcp.70509. Epub 2026 Mar 17.

    PubMed 41845869

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EP395 in people with Adult ALL, run by EpiEndo Pharmaceuticals at 1 site in United Kingdom.

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 44 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 United Kingdom. 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?

To assess the safety of EP395 (time frame: from baseline to day 7 and day 42). The study lists 6 primary outcomes in all. 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 NCT04819854, 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.

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