Single and Multiple Ascending Dose Study With EP395
A First-in Man, Phase I Study Investigating the Safety and Tolerability of EP395 in Healthy Volunteers
1 other identifier
interventional
78
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedApril 29, 2026
April 1, 2026
12 months
March 4, 2021
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
To assess the safety of EP395
Adverse Events
from baseline to day 7 and day 42
To assess the effect of EP395 on ECG
QT intervals
from baseline to day 7 and day 42
To assess the effect of EP395 on temperature
Temperature
from baseline to day 7 and day 42
To assess the effect of EP395 on blood pressure
Blood pressure
from baseline to day 7 and day 42
To assess the effect of EP395 on pulse
Pulse
from baseline to day 7 and day 42
To assess the effect of EP395 on hearing
Audiometry
from baseline to day 7 and day 42
Secondary Outcomes (4)
To assess the Cmax of EP395 in plasma and blood
from baseline to day 7 and day 42
To assess the tmax of EP395 in plasma and blood
from baseline to day 7 and day 42
To assess the t½ of EP395 in plasma and blood
from baseline to day 7 and day 42
To assess the AUC of EP395 in plasma and blood
from baseline to day 7 and day 42
Study Arms (2)
EP395
EXPERIMENTALEP395 in ascending doses. Orally, once daily.
Placebo
PLACEBO COMPARATORPlacebo, weight matched in ascending doses. Orally, once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
- Subjects with normal hearing
- Subjects must be in good health at the time of screening
You may not qualify if:
- 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
- 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.
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Medicines Evaluation Unit (MEU) Ltd.
Manchester, M23 9QZ, United Kingdom
Related Publications (1)
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 Mar 17. doi: 10.1002/bcp.70509. Online ahead of print.
PMID: 41845869RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Singh, Prof.
The Medicines Evaluation Unit (MEU) Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blinded, placebo-controlled
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2021
First Posted
March 29, 2021
Study Start
April 5, 2021
Primary Completion
March 22, 2022
Study Completion
March 22, 2022
Last Updated
April 29, 2026
Record last verified: 2026-04