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Healthy VolunteersPhase 1NCT05726851

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

A Phase 1 study testing E2025 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
E2025
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
6 Feb 2023to 30 Jan 2024
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Worldwide Clinical Trials

    San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A First-in-Human, Single Ascending Dose and Pharmacokinetic/Pharmacodynamic Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Intravenous Infusions of E2025 in Healthy Subjects

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

Being tested
E2025, Placebo
Keywords
E2025, Healthy Participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2025Drug

    E2025 IV infusion.

  • PlaceboDrug

    E2025 matched placebo IV infusion.

Study groups in NCT05726851
Study groupRoleWhat they receive
Part A, Cohort 1: E2025 Dose 1 or PlaceboExperimentalParticipants will receive E2025 Dose 1 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Receives: Drug: E2025; Drug: Placebo
Part A, Cohort 2: E2025 Dose 2 or PlaceboExperimentalParticipants will receive E2025 Dose 2 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Receives: Drug: E2025; Drug: Placebo
Part A, Cohort 3: E2025 Dose 3 or PlaceboExperimentalParticipants will receive E2025 Dose 3 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Receives: Drug: E2025; Drug: Placebo
Part A, Cohort 4: E2025 Dose 4 or PlaceboExperimentalParticipants will receive E2025 Dose 4 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Receives: Drug: E2025; Drug: Placebo
Part B, Cohort 5: E2025 Dose 2ExperimentalParticipants will receive E2025 Dose 2 administered as an IV infusion on Day 1.
Receives: Drug: E2025
Part B, Cohort 6: E2025 Dose 3ExperimentalParticipants will receive E2025 Dose 3 administered as an IV infusion on Day 1.
Receives: Drug: E2025
Part B Cohort 7: E2025 Dose 4ExperimentalParticipants will receive E2025 Dose 4 administered as an IV infusion on Day 1.
Receives: Drug: E2025

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Screening up to Day 113

  2. Number of Participants With Clinically Significant Abnormal Laboratory Values

    Measured: Screening up to Day 113

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

    Measured: Screening up to Day 113

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

    Measured: Screening up to Day 113

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

    Measured: Screening up to Day 113

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

    Measured: Screening up to Day 8

Secondary outcomes (17)

  1. Cmax: Maximum Observed Serum Concentration for E2025

    Measured: Day 1: 0-24 hours up to Day 113

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 1: 0-24 hours

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

    Measured: Day 1: 0-72 hours

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

    Measured: Day 1: 0-672 hours

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

    Measured: Day 1: 0-24 hours up to Day 113

  9. CL/F: Apparent Total Clearance for E2025

    Measured: Day 1: 0-24 hours up to Day 113

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

    Measured: Day 1: 0-24 hours up to Day 113

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

    Measured: Pre-dose; Days 8 and 29 post-dose

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

    Measured: Day 1: 0-24 hours up to Day 99

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

    Measured: 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

    Measured: Day 1: 0-24 hours

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

    Measured: 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

    Measured: Day 1: 0-24 hours

  17. Serum Concentration of Anti- E2025 Antibodies

    Measured: Day 1 up to Day 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start6 Feb 2023
  3. Primary completion30 Jan 2024
  4. Study completion30 Jan 2024

Resources

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
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726851
Sponsor's protocol ID
E2025-A001-001
Status last verified
Mar 2024
First submitted
3 Feb 2023
Last updated
25 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E2025 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.

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 2 inclusion and 20 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 25 Mar 2024. 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 States. 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. 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 Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Screening up to Day 113). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726851.

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 25 Mar 2024.

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