E2025 for Healthy Volunteers

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eisai Inc.

Must not be taking: QT prolonging drugs

Disqualifiers: Pregnancy, Psychiatric disorders, HIV, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing the safety of E2025, a substance given through an IV, in healthy adults.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions restrictions on certain medications and treatments. It's best to discuss your specific medications with the trial team to see if they are allowed.

What safety data exists for E2025 in healthy volunteers?

The safety data for E2025 in healthy volunteers is not directly available, but general safety information from phase-I studies shows that adverse events like headaches, drowsiness, and weakness can occur even with placebo treatments. It's important to note that safety reporting in clinical trials often lacks detailed information, so potential participants should be aware of this limitation. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for non-smoking adults aged 18-55 who are not pregnant, breastfeeding, or able to become pregnant. Participants must have a body weight of at least 50 kg and a BMI between 18 and <30. They should not have any significant medical conditions, abnormal test results requiring treatment, drug/alcohol abuse history in the past two years, or be taking certain medications.

Inclusion Criteria

I weigh at least 50 kg and my BMI is between 18 and 30.

Exclusion Criteria

Participants who contravene the restrictions on concomitant medications, food, beverages, physical activities, and others as defined in the protocol

You have a history of severe allergic reactions to foreign proteins, which can cause symptoms beyond just nasal or eye-related issues like in allergic rhinitis.

I am not pregnant, breastfeeding, and if I can have children, I agree to use birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of E2025 or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability after the infusion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E2025
• Placebo

Trial Overview The study tests E2025's safety when given as a single IV infusion to healthy people compared with a placebo (a substance with no active drug). It looks at how the body reacts to it (pharmacodynamics) and how it moves through and out of the body (pharmacokinetics).

How Is the Trial Designed?

Group I: Part B, Cohort 6: E2025 Dose 3 Experimental Treatment 1 Intervention

Participants will receive E2025 Dose 3 administered as an IV infusion on Day 1.

Group II: Part B, Cohort 5: E2025 Dose 2 Experimental Treatment 1 Intervention

Participants will receive E2025 Dose 2 administered as an IV infusion on Day 1.

Group III: Part B Cohort 7: E2025 Dose 4 Experimental Treatment 1 Intervention

Participants will receive E2025 Dose 4 administered as an IV infusion on Day 1.

Group IV: Part A, Cohort 4: E2025 Dose 4 or Placebo Experimental Treatment 2 Interventions

Participants will receive E2025 Dose 4 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.

Group V: Part A, Cohort 3: E2025 Dose 3 or Placebo Experimental Treatment 2 Interventions

Participants will receive E2025 Dose 3 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.

Group VI: Part A, Cohort 2: E2025 Dose 2 or Placebo Experimental Treatment 2 Interventions

Participants will receive E2025 Dose 2 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.

Group VII: Part A, Cohort 1: E2025 Dose 1 or Placebo Experimental Treatment 2 Interventions

Participants will receive E2025 Dose 1 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.

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

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

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]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A New Mechanism for Tracking Publicly Available Study Volunteer Demographics. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]