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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E8001 | Drug | Intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corrected QT (QTc) Interval | To assess the effect of E8001 on ventricular repolarization by assessing the QTc interval corrected by the Fridericia formula (QTcF). | Day 1: 0-24 hours |
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Inclusion Criteria
Exclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #1 | Minatoku | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35749284 | Derived | 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. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| Placebo | Drug | Intravenous infusion. |
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