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CompletedNCT05726851Updated Mar 25, 2024

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of E2025 in Healthy Participants

A Phase 1 interventional study of E2025 and Placebo in Healthy Volunteers, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by Eisai Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Jan 2024, 2 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) infusions of E2025 in healthy adult participants.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • E2025
  • Healthy Participants
03

In context

Lead sponsor

Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Non-smoking, male or female age greater than or equal to (>=) 18 years and less than or equal to (\<=) 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 less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening

Exclusion criteria

Exclusion Criteria:

  • Females who are breastfeeding or pregnant at Screening or Baseline; Females of childbearing potential.
  • Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period or for 203 days after their partner's study drug administration.
  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  • 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
  • Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening
  • A prolonged QT/QTc interval (QTcF >450 millisecond [ms]). A history of risk factors for torsade de pointes or the use of concomitant medications that prolonged the QT/QTc interval
  • Persistent systolic blood pressure (BP) greater than 130 millimeter of mercury (mmHg) or diastolic BP greater than 85 mmHg at Screening or Baseline; Heart rate less than 50 or more than 100 beats per minute at Screening or Baseline
  • Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-suicide Severity Rating Scale (C-SSRS) or equivalent scale or via interview with a psychiatrist
  • Any lifetime history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders); any current psychiatric symptoms as indicated by a standard screening tool.
  • Known history of clinically significant drug allergy; known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
  • Any history of hypersensitivity reaction to a foreign protein, with clinical features not limited to nasal or conjunctival symptoms such as in allergic rhinitis
  • Known to be human immunodeficiency virus positive and/or active viral hepatitis (hepatitis B core antibody [HBcAb], hepatitis B viral protein [HBcAg], hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [HCVAb]) as demonstrated by positive serology at Screening
  • History of drug or alcohol dependency or abuse within the 2 years before Screening, or a positive urine drug test or breath alcohol test at Screening or Baseline
  • Currently enrolled in another clinical study or used any investigational drug or device within 28 days (or 5*the half-life, whichever is longer) preceding informed consent
  • Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
  • Exposure to any biologic drug within 90 days or at least 5 half-lives (whichever is longer), or within 4 weeks for vaccines, before Screening, with the exception of flu (7 days before dosing) and COVID-19 vaccination (14 days before dosing until after the Follow-up visit).
  • Any contraindication to continuous CSF sampling via indwelling lumbar catheter or via lumbar puncture (LP)
  • Participants identified at risk for hemorrhage.
  • Inadequate venous access that would interfere with study drug administration or obtaining blood samples
  • Participants who contravene the restrictions on concomitant medications, food, beverages, physical activities, and others as defined in the protocol
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Part A, Cohort 1: E2025 Dose 1 or Placebo

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

    Drug: E2025 · Drug: Placebo

  • Experimental
    Part A, Cohort 2: E2025 Dose 2 or Placebo

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

    Drug: E2025 · Drug: Placebo

  • Experimental
    Part A, Cohort 3: E2025 Dose 3 or Placebo

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

    Drug: E2025 · Drug: Placebo

  • Experimental
    Part A, Cohort 4: E2025 Dose 4 or Placebo

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

    Drug: E2025 · Drug: Placebo

  • Experimental
    Part B, Cohort 5: E2025 Dose 2

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

    Drug: E2025

  • Experimental
    Part B, Cohort 6: E2025 Dose 3

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

    Drug: E2025

  • Experimental
    Part B Cohort 7: E2025 Dose 4

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

    Drug: E2025

Interventions

  • DrugE2025

    E2025 IV infusion.

  • DrugPlacebo

    E2025 matched placebo IV infusion.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Screening up to Day 113

  2. Number of Participants With Clinically Significant Abnormal Laboratory Values

    Time frame: Screening up to Day 113

  3. Number of Participants With Clinically Significant Abnormal Vital Signs Values

    Time frame: Screening up to Day 113

  4. Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings

    Time frame: Screening up to Day 113

  5. Number of Participants With Clinically Significant Abnormal Physical Examinations Findings

    Time frame: Screening up to Day 113

  6. Number of Participants With Clinically Significant Abnormal Psychiatric Examination Findings

    Time frame: Screening up to Day 8

Secondary outcomes

  1. Cmax: Maximum Observed Serum Concentration for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  2. Tmax: Time to Reach Maximum Observed Serum Concentration (Cmax) for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  3. AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Last Quantifiable Concentration for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  4. AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Infinite for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  5. AUC(0-24h): Area Under the Serum Concentration-time Curve From Time Zero to 24 hours for E2025

    Time frame: Day 1: 0-24 hours

  6. AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 hours for E2025

    Time frame: Day 1: 0-72 hours

  7. AUC(0-672h): Area Under the Serum Concentration-time Curve From Time Zero to 672 hours for E2025

    Time frame: Day 1: 0-672 hours

  8. t1/2: Terminal Elimination Phase Half-life for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  9. CL/F: Apparent Total Clearance for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  10. Vss: Volume of Distribution at Steady State for E2025

    Time frame: Day 1: 0-24 hours up to Day 113

  11. Part A: Cerebrospinal Fluid (CSF) Concentrations for E2025

    Time frame: Pre-dose; Days 8 and 29 post-dose

  12. Part B, CSF Cmax: Maximum Observed CSF Concentration for E2025

    Time frame: Day 1: 0-24 hours up to Day 99

  13. Part B, CSF Tmax: Time to Reach Maximum Observed CSF Concentration (Cmax) for E2025

    Time frame: Day 1: 0-24 hours up to Day 99

  14. Part B, CSF AUC(0-24h): Area Under the CSF Concentration-time Curve From Time Zero to 24 hours for E2025

    Time frame: Day 1: 0-24 hours

  15. Part B: Ratio of Cmax in CSF and Cmax in Serum for E2025

    Time frame: Day 1: 0-24 hours up to Day 99

  16. Part B: Ratio of AUC(0-24h) in CSF and AUC(0-24h) in Serum for E2025

    Time frame: Day 1: 0-24 hours

  17. Serum Concentration of Anti- E2025 Antibodies

    Time frame: Day 1 up to Day 113

07

Study locations

1 site
  • Worldwide Clinical Trials
    San Antonio, Texas 78217, United States
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05726851
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Feb 14, 2023
Start date
Feb 6, 2023
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Mar 25, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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