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

NCT05726851 | Completed Phase 1 FDA Drug

• 1 other identifier: E2025-A001-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

E2025; Healthy Participants

Outcome Measures

Primary Outcomes (6)

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

  Screening up to Day 113

• Number of Participants With Clinically Significant Abnormal Laboratory Values

  Screening up to Day 113

• Number of Participants With Clinically Significant Abnormal Vital Signs Values

  Screening up to Day 113

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

  Screening up to Day 113

• Number of Participants With Clinically Significant Abnormal Physical Examinations Findings

  Screening up to Day 113

• Number of Participants With Clinically Significant Abnormal Psychiatric Examination Findings

  Screening up to Day 8

Secondary Outcomes (17)

• Cmax: Maximum Observed Serum Concentration for E2025

  Day 1: 0-24 hours up to Day 113

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

  Day 1: 0-24 hours up to Day 113

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

  Day 1: 0-24 hours up to Day 113

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

  Day 1: 0-24 hours up to Day 113

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

  Day 1: 0-24 hours

Study Arms (7)

Part A, Cohort 1: E2025 Dose 1 or Placebo

EXPERIMENTAL

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

Drug: E2025; Drug: Placebo

Part A, Cohort 2: E2025 Dose 2 or Placebo

EXPERIMENTAL

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

Drug: E2025; Drug: Placebo

Part A, Cohort 3: E2025 Dose 3 or Placebo

EXPERIMENTAL

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

Drug: E2025; Drug: Placebo

Part A, Cohort 4: E2025 Dose 4 or Placebo

EXPERIMENTAL

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

Drug: E2025; Drug: Placebo

Part B, Cohort 5: E2025 Dose 2

EXPERIMENTAL

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

Drug: E2025

Part B, Cohort 6: E2025 Dose 3

EXPERIMENTAL

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

Drug: E2025

Part B Cohort 7: E2025 Dose 4

EXPERIMENTAL

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

Drug: E2025

Interventions

E2025 DRUG

E2025 IV infusion.

Part A, Cohort 1: E2025 Dose 1 or Placebo; Part A, Cohort 2: E2025 Dose 2 or Placebo; Part A, Cohort 3: E2025 Dose 3 or Placebo; Part A, Cohort 4: E2025 Dose 4 or Placebo; Part B Cohort 7: E2025 Dose 4; Part B, Cohort 5: E2025 Dose 2; Part B, Cohort 6: E2025 Dose 3

Placebo DRUG

E2025 matched placebo IV infusion.

Part A, Cohort 1: E2025 Dose 1 or Placebo; Part A, Cohort 2: E2025 Dose 2 or Placebo; Part A, Cohort 3: E2025 Dose 3 or Placebo; Part A, Cohort 4: E2025 Dose 4 or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: February 6, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)