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

NCT ID: NCT04609852

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2023-08-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Cohort 1: E8001 or Placebo

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

Group Type: EXPERIMENTAL

E8001

Intervention Type: DRUG

Intravenous infusion.

Placebo

Intervention Type: DRUG

Intravenous infusion.

Cohort 2: E8001 or Placebo

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

Group Type: EXPERIMENTAL

E8001

Intervention Type: DRUG

Intravenous infusion.

Placebo

Intervention Type: DRUG

Intravenous infusion.

Cohort 3: E8001 or Placebo

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

Group Type: EXPERIMENTAL

E8001

Intervention Type: DRUG

Intravenous infusion.

Placebo

Intervention Type: DRUG

Intravenous infusion.

Cohort 4: E8001 or Placebo

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

Group Type: EXPERIMENTAL

E8001

Intervention Type: DRUG

Intravenous infusion.

Placebo

Intervention Type: DRUG

Intravenous infusion.

Interventions

E8001

Intravenous infusion.

Intervention Type: DRUG

Placebo

Intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. Body mass index (BMI) >=18.5 and less than (<) 25.0 kilogram per square meter (kg/m˄2) at Screening

Exclusion Criteria

1. 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

2. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing

3. History of meningococcal infection or pneumococcal infection

4. 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

5. Any history of gastrointestinal surgery that may affect PK profiles of E8001, example- hepatectomy, nephrectomy, and digestive organ resection at Screening

6. 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

7. History of prolonged QT/QTc interval

8. History of left bundle branch block (LBBB)

9. History of myocardial infarction (MI) or active ischemic heart disease (IHD)

10. History of clinically significant arrhythmia or uncontrolled arrhythmia

11. Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology at Screening

12. History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline

13. Liver function test with following values at Screening or Baseline:

1. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma glutamyl transpeptidase (GGT): greater than (>) upper limit of normal (ULN)

2. direct bilirubin or total bilirubin: >1.5*ULN

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Trial Site #1

Minatoku, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 35749284 (View on PubMed)

Other Identifiers

E8001-J081-001

Identifier Type: -

Identifier Source: org_study_id