What side effects are associated with this type of intervention?

Common side effects for treatments involving single intravenous infusions, such as the one being studied for E2025, typically include local injection site reactions like erythema, pain, or bruising. Other potential side effects may include dizziness, headache, and nausea. Serious adverse effects are generally uncommon, but hypersensitivity reactions such as rash, pruritus, and urticaria can occur. It is important to monitor for any adverse events during and after the infusion.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects often focus on evaluating the safety and tolerability of new drugs or therapies. These studies typically involve single or multiple doses administered to healthy volunteers to assess adverse effects, pharmacokinetics, and pharmacodynamics. While specific drugs similar to E2025 are not detailed, the general approach involves rigorous clinical trials to ensure that any new treatment is safe for human use before proceeding to patient populations.

What other types of research exist?

Promising novel alternatives to E2025 for healthy subjects in 2024 include ABCB5+ MSCs (allo-APZ2-EB) for its safety and efficacy in reducing disease activity and symptoms in epidermolysis bullosa, and niraparib, a PARP inhibitor showing activity in prostate cancer patients with BRCA mutations. Both therapies have shown potential in early-phase trials and are being further evaluated for their safety and tolerability.

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Other

E2025 for Healthy Volunteers

Q: What is the mechanism of action of this treatment?

Intravenous (IV) treatments, like the one being studied in the E2025 trial, deliver medications directly into the bloodstream, allowing for rapid and controlled absorption. This method ensures precise dosing and immediate therapeutic effects, which is crucial for assessing the safety and tolerability of new drugs in healthy subjects. Establishing this baseline data is essential to ensure that the drug does not cause adverse effects before being tested in patients with specific conditions.

Phase 1

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-smoking, male or female age >=18 years and <=55 years old at the time of informed consent. Females must be of nonchildbearing potential

Body weight >=50 kilogram (kg) and a Body Mass Index (BMI) >=18 and <30 kilogram per square meter (kg/m^2) at Screening

Must not have

Females who are breastfeeding or pregnant at Screening or Baseline; Females of childbearing potential

Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects aren't listed since this is an early-phase trial assessing safety in healthy volunteers, potential side effects could include reactions at the infusion site, allergic responses due to foreign protein sensitivity, or other unforeseen reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a non-smoker, aged 18-55, and cannot become pregnant.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any major health issues that could affect the study results.

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I have no symptoms or test results that need treatment right now.

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My heart's electrical cycle is longer than normal, or I take medications that can extend this cycle.

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My blood pressure is high or my heart rate is not between 50-100 beats per minute.

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I haven't received blood products in the last 4 weeks or donated blood or plasma recently.

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I cannot have a lumbar catheter or lumbar puncture due to health reasons.

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I am at risk for bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part B, Cohort 6: E2025 Dose 3Experimental Treatment1 Intervention

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

Group II: Part B, Cohort 5: E2025 Dose 2Experimental Treatment1 Intervention

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

Group III: Part B Cohort 7: E2025 Dose 4Experimental Treatment1 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 PlaceboExperimental Treatment2 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 PlaceboExperimental Treatment2 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 PlaceboExperimental Treatment2 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 PlaceboExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

E2025

2023

Completed Phase 1

~40

Placebo

1995

Completed Phase 3

~2670

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous (IV) treatments, like the one being studied in the E2025 trial, deliver medications directly into the bloodstream, allowing for rapid and controlled absorption. This method ensures precise dosing and immediate therapeutic effects, which is crucial for assessing the safety and tolerability of new drugs in healthy subjects. Establishing this baseline data is essential to ensure that the drug does not cause adverse effects before being tested in patients with specific conditions.

Fluoroquinolones in the management of tuberculous meningitis: Systematic review and meta-analysis.Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update.Practice parameters for the nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine report. Standards of Practice Committee of the American Academy of Sleep Medicine.