A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects
NCT ID: NCT03014895
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
29 participants
INTERVENTIONAL
2017-01-25
2017-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Cohort 1: Placebo
Intravenous placebo infusion
Placebo
Intravenous infusion
Cohort 1: E3112
Intravenous E3112 infusion
E3112
Intravenous infusion
Cohort 2: Placebo
Intravenous placebo infusion
Placebo
Intravenous infusion
Cohort 2: E3112
Intravenous E3112 infusion
E3112
Intravenous infusion
Cohort 3: Placebo
Intravenous placebo infusion
Placebo
Intravenous infusion
Cohort 3: E3112
Intravenous E3112 infusion
E3112
Intravenous infusion
Cohort 4: Placebo
Intravenous placebo infusion
Placebo
Intravenous infusion
Cohort 4: E3112
Intravenous E3112 infusion
E3112
Intravenous infusion
Cohort 5: Placebo
Intravenous placebo infusion
Placebo
Intravenous infusion
Cohort 5: E3112
Intravenous E3112 infusion
E3112
Intravenous infusion
Interventions
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Placebo
Intravenous infusion
E3112
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Have a Body Mass Index (BMI) ≥18.5 and \<25.0 kilograms per meters squared (kg/m\^2) at Screening
* Able to provide written informed consent of their free will
* Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them
Exclusion Criteria
* Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
* Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
* Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
* Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
* Receipt of vaccination within 4 weeks prior to dosing
* History of drug or alcohol dependency or abuse prior to Screening
* Intake of caffeinated beverages or food within 72 hours prior to dosing
* Use of prescription drugs within 4 weeks prior to dosing
* Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
* Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
* Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing
20 Years
44 Years
MALE
Yes
Sponsors
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EA Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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EA Pharma Trial Site
Toshima City, Tokyo, Japan
Countries
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Other Identifiers
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E3112/CP1
Identifier Type: -
Identifier Source: org_study_id
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