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Completed

NCT Number: NCT03922633

A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.

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Key information

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

EA Pharma Trial Site

Higashi, Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
  • Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
  • Written, informed consent to participate in the study based on the participant's own free will
  • Willing and able to comply with the requirements in the study after being fully informed of the requirements

Exclusion criteria

  • Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
  • A history or complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disorder, a clinically significant disease requiring treatments within 8 weeks before the investigational product treatment, or a history of a clinically significant infection within 4 weeks before the investigational product treatment
  • With a psychiatric, digestive, hepatic, renal, respiratory, endocrine, hematologic, neural, or cardiovascular disease within 4 weeks before the investigational product treatment, a congenital metabolic abnormality, or otherwise a disease that may affect the drug assessments
  • With a surgical history (e.g., resection of the liver, kidney, or digestive tract, etc.) at screening that may affect the pharmacokinetics of the investigational product
  • Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
  • Testing positive for human immunodeficiency virus (HIV) at screening
  • A positive response to a qualitative test for hepatitis B virus surface antigen (HBs antigen), hepatitis B virus core antigen (HBc) antibody, hepatitis C virus (HCV) antibody, or syphilis
  • Use of a prescription drug within 4 weeks before the investigational product treatment
  • Use of an over-the-counter drug within 2 weeks before the investigational product treatment
  • Receiving a vaccine within 4 weeks before the investigational product treatment
  • Ongoing participation in another clinical study or use of an investigational product or device within 16 weeks before the investigational product treatment while participating in another clinical study
  • Receiving blood transfusion within 12 weeks before the investigational product treatment, providing a whole-blood sample of 400 millilitre (mL) or more between 12 to 4 weeks before the investigational product treatment or a whole-blood sample of 200 mL or more within 4 weeks before the investigational product treatment, or giving blood components by pheresis within 2 weeks before the investigational product treatment

Treatment and study plan

E3112

Drug

Intravenous infusion.

Placebo

Other

Intravenous infusion.

Primary outcomes

  1. Serum Concentrations of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

  2. Change from Baseline in Serum Concentration of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

  3. Peak Concentration (Cmax) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

    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.

  4. Time to Peak Concentration (Tmax) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

    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.

  5. Area Under the Concentration-time Curve (AUC 0-t) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

    AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.

  6. Area Under the Concentration-time Curve (AUC∞) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

    AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.

  7. Half-life of Elimination (t1/2) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

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

  8. Clearance (CL) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

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

  9. Volume of Distribution (Vd) of E3112

    Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours

    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 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 to Day 43

  2. Number of Participants with an Abnormal, Clinically Significant Hematology parameter value

    Time frame: Day 1 to Day 43

  3. Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value

    Time frame: Day 1 to Day 43

  4. Number of Participants with an Abnormal, Clinically Significant Urine Value

    Time frame: Day 1 to Day 43

  5. Number of Participants with Clinically Significant Change in Vital Signs

    Time frame: Day 1 to Day 43

  6. Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)

    Time frame: Day 1 to Day 43

  7. Number of Participants with Clinically Significant Change in Physical Findings

    Time frame: Day 1 to Day 43

  8. Number of Participants with Clinically Significant Change in Ophthalmological Findings

    Time frame: Day 1 to Day 43

  9. Percentage of Participants with Serum Anti-E3112 Antibodies

    Time frame: Day 1 to Day 43

Sponsors and collaborators

Lead sponsor

EA Pharma Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2019
Registry last updated
Mar 15, 2021

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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