Healthy VolunteersPhase 1NCT02998190
First-in-Human Single and Multiple Dose of EB8018
A Phase 1 study testing Single Ascending Doses of EB8018 and Multiple Ascending Doses of EB8018 in people with Healthy Volunteers, run by Enterome at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Single Ascending Doses of EB8018 and Multiple Ascending Doses of EB8018
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Aug 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age ≥ 18 to ≤ 55 years of age
- Body mass index of 19.0 to 30.0 kg/m2
- Normal ECG, showing no clinically relevant deviations, as judged by the investigator (QTcF ≤450 ms)
Who cannot join
- Subjects who have received any Investigational Medicinal Product in a clinical research study within the previous 3 months.
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week
- Current smokers and those who have smoked within the last 12 months
- Positive drugs of abuse test result
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever, even inactive, is not allowed.
- Chronic infection or acute significant infection or fever within the previous 5 weeks prior to the start of IMP administration
- Malignancy or prior malignancy, with a disease-free interval of less than 5 years after diagnosis and intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of a FimH Antagonist, EB8018, in Healthy Volunteers.
The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.
Read the detailed description
Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging evidence suggests that the microbiome plays an important role in triggering an abnormal mucosal immune response in patients with Crohn's Disease. Independent studies have demonstrated an imbalance of the microbiome with a significant increase of E coli with invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral small molecule that is designed to block FimH thereby preventing the entry of AIEC into the gut wall thereby disarming the bacteria without disrupting the gut microbiome.
- Conditions
- Healthy Volunteers
- Being tested
- Single Ascending Doses of EB8018, Single Ascending Doses of placebo, Multiple Ascending Doses of EB8018, Multiple Ascending Doses of placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Ascending Doses of EB8018Drug
Single Ascending Doses of placeboDrug
Multiple Ascending Doses of EB8018Drug
Multiple Ascending Doses of placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose of EB8018 | Experimental | Single ascending doses, sequential group design Receives: Drug: Single Ascending Doses of EB8018 |
| Single oral dose of placebo | Placebo comparator | Single doses, matching placebo Receives: Drug: Single Ascending Doses of placebo |
| Multiple oral doses of EB8018 | Experimental | Multiple ascending doses, daily for 14 days Receives: Drug: Multiple Ascending Doses of EB8018 |
| Multiple oral doses of placebo | Placebo comparator | Multiple ascending doses, daily for 14 days Receives: Drug: Multiple Ascending Doses of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events to evaluate the safety and tolerability profile of single ascending and multiple ascending doses of EB8018 compared with placebo in healthy subjects
The variables for analysis will be the difference of EB8018 compared with placebo for incidence, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
Measured: Between screening and 7-10 days after the last dose
Secondary outcomes (4)
The amount of EB8018 in plasma
To characterize the amount of EB8018 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Measured: Between Day 1 predose and 48 hours after the (last) dose
The amount of EB8018 in urine
To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Measured: Between Day 1 predose and 48 hours after the (last) dose
The amount of EB8018 in stool
To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Measured: Between predose and 48 hours after the (last) dose
Analysis of microbiome richness
To compare the abundance of gene richness, all phyla and certain species such as E. Coli
Measured: Between predose and 48 hours after the (last) dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enterome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998190
- Sponsor's protocol ID
- EBFIM116
- Status last verified
- Feb 2018
- First submitted
- 13 Dec 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of a FimH Antagonist, EB8018, in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02998190
- Acronym / sponsor ID
- EBFIM116
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EnteromeIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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 purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.
Detailed description
Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging evidence suggests that the microbiome plays an important role in triggering an abnormal mucosal immune response in patients with Crohn's Disease. Independent studies have demonstrated an imbalance of the microbiome with a significant increase of E coli with invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral small molecule that is designed to block FimH thereby preventing the entry of AIEC into the gut wall thereby disarming the bacteria without disrupting the gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single oral dose of EB8018 | Experimental | Drug: Single Ascending Doses of EB8018Single ascending doses, sequential group design |
| Single oral dose of placebo | Placebo comparator | Drug: Single Ascending Doses of placeboSingle doses, matching placebo |
| Multiple oral doses of EB8018 | Experimental | Drug: Multiple Ascending Doses of EB8018Multiple ascending doses, daily for 14 days |
| Multiple oral doses of placebo | Placebo comparator | Drug: Multiple Ascending Doses of placeboMultiple ascending doses, daily for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- Age ≥ 18 to ≤ 55 years of age
- Body mass index of 19.0 to 30.0 kg/m2
- Normal ECG, showing no clinically relevant deviations, as judged by the investigator (QTcF ≤450 ms)
Key exclusion criteria (8 listed)
- Subjects who have received any Investigational Medicinal Product in a clinical research study within the previous 3 months.
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week
- Current smokers and those who have smoked within the last 12 months
- Positive drugs of abuse test result
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 |
|---|---|---|
| Single Ascending Doses of EB8018 | Drug | Single oral dose of EB8018 |
| Single Ascending Doses of placebo | Drug | Single oral dose of placebo |
| Multiple Ascending Doses of EB8018 | Drug | Multiple oral doses of EB8018 |
| Multiple Ascending Doses of placebo | Drug | Multiple oral doses of placebo |
Primary outcome
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events to evaluate the safety and tolerability profile of single ascending and multiple ascending doses of EB8018 compared with placebo in healthy subjects
Time frame: Between screening and 7-10 days after the last dose
The variables for analysis will be the difference of EB8018 compared with placebo for incidence, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
4 secondary outcomes
The amount of EB8018 in plasma
Time frame: Between Day 1 predose and 48 hours after the (last) dose
The amount of EB8018 in urine
Time frame: Between Day 1 predose and 48 hours after the (last) dose
The amount of EB8018 in stool
Time frame: Between predose and 48 hours after the (last) dose
Analysis of microbiome richness
Time frame: Between predose and 48 hours after the (last) dose
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 13 Feb 2018.
- Individual participant dataSharing planned: No
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Healthy Participants
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 Single Ascending Doses of EB8018 and Multiple Ascending Doses of EB8018 in people with Healthy Volunteers, run by Enterome 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 4 inclusion and 8 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 13 Feb 2018. 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?
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events to evaluate the safety and tolerability profile of single ascending and multiple ascending doses of EB8018 compared with placebo in healthy subjects (time frame: Between screening and 7-10 days after the last dose). 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 13 Feb 2018.