A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants

NCT04609852 | Completed Phase 1

• 1 other identifier: E8001-J081-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.

Conditions

Healthy Volunteers

Keywords

Healthy Participants; E8001

Outcome Measures

Primary Outcomes (7)

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

  Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; regular monitoring of clinical laboratory parameters; and periodic measurement of vital signs and 12-lead electrocardiogram (ECG), body weight and physical examinations.

  Screening up to Day 180 (approximately 292 days)

• Cmax: Maximum Observed Plasma Concentration for E8001

  Day 1: 0-168 hours

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001

  Day 1: 0-168 hours

• AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E8001

  Day 1: 0-168 hours

• T1/2: Terminal Elimination Phase Half-life for E8001

  Day 1: 0-168 hours

• CL: Total Clearance for E8001

  Day 1: 0-168 hours

• Vss: Volume of Distribution at Steady State for E8001

  Day 1: 0-168 hours

Secondary Outcomes (1)

• Change From Baseline in Corrected QT (QTc) Interval

  Day 1: 0-24 hours

Study Arms (4)

Cohort 1: E8001 or Placebo

EXPERIMENTAL

Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.

Drug: E8001; Drug: Placebo

Cohort 2: E8001 or Placebo

EXPERIMENTAL

Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.

Drug: E8001; Drug: Placebo

Cohort 3: E8001 or Placebo

EXPERIMENTAL

Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.

Drug: E8001; Drug: Placebo

Cohort 4: E8001 or Placebo

EXPERIMENTAL

Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.

Drug: E8001; Drug: Placebo

Interventions

E8001 DRUG

Intravenous infusion.

Cohort 1: E8001 or Placebo; Cohort 2: E8001 or Placebo; Cohort 3: E8001 or Placebo; Cohort 4: E8001 or Placebo

Placebo DRUG

Intravenous infusion.

Cohort 1: E8001 or Placebo; Cohort 2: E8001 or Placebo; Cohort 3: E8001 or Placebo; Cohort 4: E8001 or Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking, age greater than or equal to (\>=) 20 years and less than or equal to (\<=) 55 years old adult male at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
• Body mass index (BMI) \>=18.5 and less than (\<) 25.0 kilogram per square meter (kg/m˄2) at Screening

You may not qualify if:

• Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation
• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
• History of meningococcal infection or pneumococcal infection
• 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 history of gastrointestinal surgery that may affect PK profiles of E8001, example- hepatectomy, nephrectomy, and digestive organ resection at Screening
• 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 or Baseline
• History of prolonged QT/QTc interval
• History of left bundle branch block (LBBB)
• History of myocardial infarction (MI) or active ischemic heart disease (IHD)
• History of clinically significant arrhythmia or uncontrolled arrhythmia
• Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology at Screening
• History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline
• Liver function test with following values at Screening or Baseline:
• aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma glutamyl transpeptidase (GGT): greater than (\>) upper limit of normal (ULN)
• direct bilirubin or total bilirubin: \>1.5\*ULN

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Eisai Trial Site #1

Minatoku, Japan

Location

Related Publications (1)

• Ishigooka H, Katsumata H, Saiga K, Tokita D, Motoi S, Matsui C, Suzuki Y, Tomimatsu A, Nakatani T, Kuboi Y, Yamakawa T, Ikeda T, Ishii R, Imai T, Takagi T, Tanabe K. Novel Complement C5 Small-interfering RNA Lipid Nanoparticle Prolongs Graft Survival in a Hypersensitized Rat Kidney Transplant Model. Transplantation. 2022 Dec 1;106(12):2338-2347. doi: 10.1097/TP.0000000000004207. Epub 2022 Nov 22.

  PMID: 35749284 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: October 28, 2020
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)