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Completed

NCT Number: NCT03014895

A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects

The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.

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Key information

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

EA Pharma Trial Site

Toshima City, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Main Inclusion Criteria:

  • Non-smoking, Japanese, male participants, ≥20 and <45 years old at the time of obtaining informed consent
  • 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

Main Exclusion Criteria:

  • Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
  • 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

Treatment and study plan

Placebo

Drug

Intravenous infusion

E3112

Drug

Intravenous infusion

Primary outcomes

  1. Peak concentration (Cmax) of E3112

    Time frame: Days 1 to 4, 8, 14, and 28

    Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.

  2. Time to peak concentration (Tmax) of E3112

    Time frame: Days 1 to 4, 8, 14, and 28

    Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.

  3. Area under the curve (AUC)

    Time frame: Days 1 to 4, 8, 14, and 28

    AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.

  4. Half-life of elimination (t1/2) of E3112

    Time frame: Days 1 to 4, 8, 14, and 28

    t1/2 is the time required for the concentration of the drug to reach half of its original value.

  5. Clearance of E3112

    Time frame: Days 1 to 4, 8, 14, and 28

    Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.

  6. Volume of distribution (Vd) of E3112

    Time frame: Days 1 to 4, 8, 14, and 28

    Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.

Secondary outcomes

  1. Number of participants with any serious adverse event and any non-serious adverse event

    Time frame: Days 1 to 28

    An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.

  2. Number of participants with an abnormal, clinically significant hematology parameter value

    Time frame: Days 1 to 28

    Clinical significance will be determined by the investigator.

  3. Number of participants with an abnormal, clinically significant blood chemistry parameter value

    Time frame: Days 1 to 28

    Clinical significance will be determined by the investigator.

  4. Number of participants with an abnormal, clinically significant urine value

    Time frame: Days 1 to 28

    Clinical significance will be determined by the investigator.

  5. Number of participants with an abnormal, clinically significant vital sign measurement

    Time frame: Baseline; Days 1 to 28

    Clinical significance will be determined by the investigator.

  6. Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement

    Time frame: Baseline; Days 1 to 28

    Clinical significance will be determined by the investigator.

  7. Number of participants with an abnormal, clinically significant physical examination measurement

    Time frame: Baseline; Days 1 to 28

    Clinical significance will be determined by the investigator.

Sponsors and collaborators

Lead sponsor

EA Pharma Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2017
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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