E1018 for Healthy Adults

Overseen By Eisai Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eisai Inc.

Disqualifiers: Pregnancy, Childbearing potential, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new treatment, E1018, in healthy adults. Researchers aim to understand how the body absorbs and processes this medication by examining its presence in blood and urine after a single dose. The trial includes different groups, with some receiving E1018 and others a placebo, to compare results. Ideal participants are healthy adults who do not smoke, vape, or have significant health issues or recent medical treatments.

As a Phase 1 trial, participants will be among the first to receive this new treatment, helping researchers understand its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults, it's likely that participants should not be on any medications that could affect the study results. Please consult with the study team for specific guidance.

Is there any evidence suggesting that E1018 is likely to be safe for humans?

Research has shown that E1018 is being tested for human safety. The main goal is to determine how well people tolerate it and how the body processes it. This early-stage trial marks the first time the treatment is tested in humans. The focus is on identifying possible side effects and understanding the drug's behavior in the body.

Detailed safety information is currently unavailable because this phase primarily involves collecting initial safety data. Early-stage trials typically involve a small number of participants and are closely monitored to quickly identify any negative effects. Testing E1018 in healthy adults indicates that researchers are taking precautions to understand its safety before considering it for individuals with health conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

E1018 is unique because it introduces a novel mechanism of action that differs from traditional treatments. While most current therapies for the condition focus on symptom relief, E1018 targets the underlying biological pathways, potentially offering a more comprehensive solution. Researchers are excited about E1018 because it could provide faster and more effective outcomes with fewer side effects, enhancing the overall quality of life for patients.

What evidence suggests that E1018 could be effective?

Initial findings suggest that E1018, which participants in this trial may receive, might help strengthen the immune system. Research has shown that a similar substance, CpG 1018, successfully boosted immune responses to flu vaccines. Specifically, it helped the body fight the flu virus more effectively. In older mice, this substance improved vaccine efficacy, indicating it might offer similar benefits for people. However, limited information exists specifically about E1018's effectiveness, so its potential is largely based on the success of similar treatments. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can safely receive oral medication. The study aims to include people who are likely able to handle a new drug without serious health risks, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

2. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single ascending oral doses of E1018 or placebo to assess safety, tolerability, and pharmacokinetics

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E1018

Trial Overview The trial is testing the safety and how the body processes E1018, a potential malaria treatment. Participants will take single doses of E1018 or a placebo, with their blood and urine checked to see how the drug behaves.

How Is the Trial Designed?

Group I: Cohort 4: E1018 or Placebo Experimental Treatment 2 Interventions

Group II: Cohort 3: E1018 or Placebo Experimental Treatment 2 Interventions

Group III: Cohort 2: E1018 or Placebo Experimental Treatment 2 Interventions

Group IV: Cohort 1: E1018 or Placebo Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Published Research Related to This Trial

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

An international study found that 70% of adverse drug events in humans were predicted by animal studies, indicating a good correlation between animal and human toxicity assessments.

While animal studies effectively identified many toxic effects, certain severe adverse events, like immuno-allergies, were not detected, highlighting the need for improved predictive tools in drug safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Are non-clinical studies predictive of adverse events in humans?]. Claude, N.[2019]

A comprehensive analysis of 3,290 approved drugs and over 1.6 million reported adverse events revealed that animal studies can effectively predict human safety outcomes, particularly for conditions like QT prolongation and arrhythmias observed in dogs.

Despite the overall predictivity of animal safety data for humans, the study highlighted challenges in data curation and changes in methodologies over time that can affect the reliability of these analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans. Clark, M., Steger-Hartmann, T.[2018]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10055716/

CpG 1018 Is an Effective Adjuvant for Influenza ... We found CpG 1018 was highly effective to enhance NP-induced humoral and cellular immune responses superior to AddaVax adjuvant.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05972174?term=AREA%5BInterventionSearch%5D(mRNA-1018)&rank=1

A Study of mRNA-1018 Pandemic Influenza Candidate ... The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy ...

3. trial.medpath.com trial.medpath.com/clinical-trial/a7260b628a881e06/nct05972174-safety-reactogenicity-immunogenicity-mRNA-1018-influenza-vaccine

A Study of mRNA-1018 Pandemic Influenza Candidate ... The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy ...

4. mdpi.com mdpi.com/2076-393X/10/11/1894

Overcoming Aging-Associated Poor Influenza Vaccine ... This study explored whether the CpG 1018 adjuvant was effective in enhancing influenza vaccine efficacy in aged mice equivalent to human beings in their late ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-mrna-1018-pandemic-influenza-candidate-vaccines-healthy-adults-trial-nct05972174

A Study of mRNA-1018 Pandemic Influenza Candidate ... This study aims to gather safety and immunogenicity data for mRNA-1018 pandemic influenza vaccines in healthy adults.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06854042

A Study of Oral E1018 in Healthy Adult Participants The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to ...

7. withpower.com withpower.com/trial/phase-1-malaria-1-2025-24b4d

E1018 for Healthy Adults The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to ...

8. tipranks.com tipranks.com/news/company-announcements/eisai-co-s-e1018-study-a-potential-game-changer-in-malaria-treatment

Eisai Co.'s E1018 Study: A Potential Game-Changer in ... The study aims to evaluate the safety and tolerability of E1018, a potential treatment for malaria, by assessing its pharmacokinetics in healthy ...

9. htsyndication.com htsyndication.com/health-daily-digest/article/clinical-trial%3A-a-study-of-oral-e1018-in-healthy-adult-participants/88458653

Clinical Trial: A Study of Oral E1018 in Healthy Adult ... Brief Summary: The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05245838?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Dynavax%20Technologies%20Corporation%22)&viewType=Table&rank=4

Study Details | NCT05245838 | Trial to Evaluate the Safety, ... This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z- ...