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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Participants
• Intervention / Treatment: Drug: E3112; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Higashi, Fukuoka, Japan
      • EA Pharma Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
2. 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
3. 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
4. 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
5. 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
6. Testing positive for human immunodeficiency virus (HIV) at screening
7. 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
8. Use of a prescription drug within 4 weeks before the investigational product treatment
9. Use of an over-the-counter drug within 2 weeks before the investigational product treatment
10. Receiving a vaccine within 4 weeks before the investigational product treatment
11. 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
12. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1 Group A: E3112 + Placebo; E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 1 Group B: Placebo + E3112; Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 2 Group A: E3112 + Placebo; E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 2 Group B: Placebo + E3112; Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 3 Group A: E3112 + Placebo; E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 3 Group B: Placebo + E3112; Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 4 Group A: E3112 + Placebo; E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.
EXPERIMENTAL: Cohort 4 Group B: Placebo + E3112; Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.	Drug: E3112; Intravenous infusion.; Other: Placebo; Intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentrations of E3112		Day 1: 0-24 hours; Day 8: 0-24 hours
Change from Baseline in Serum Concentration of E3112		Day 1: 0-24 hours; Day 8: 0-24 hours
Peak Concentration (Cmax) of E3112	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.	Day 1: 0-24 hours; Day 8: 0-24 hours
Time to Peak Concentration (Tmax) of E3112	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.	Day 1: 0-24 hours; Day 8: 0-24 hours
Area Under the Concentration-time Curve (AUC 0-t) of E3112	AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.	Day 1: 0-24 hours; Day 8: 0-24 hours
Area Under the Concentration-time Curve (AUC∞) of E3112	AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.	Day 1: 0-24 hours; Day 8: 0-24 hours
Half-life of Elimination (t1/2) of E3112	t1/2 is the time required for the concentration of the drug to reach half of its original value.	Day 1: 0-24 hours; Day 8: 0-24 hours
Clearance (CL) of E3112	CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.	Day 1: 0-24 hours; Day 8: 0-24 hours
Volume of Distribution (Vd) of E3112	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.	Day 1: 0-24 hours; Day 8: 0-24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Hematology parameter value	Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value	Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Urine Value	Day 1 to Day 43
Number of Participants with Clinically Significant Change in Vital Signs	Day 1 to Day 43
Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)	Day 1 to Day 43
Number of Participants with Clinically Significant Change in Physical Findings	Day 1 to Day 43
Number of Participants with Clinically Significant Change in Ophthalmological Findings	Day 1 to Day 43
Percentage of Participants with Serum Anti-E3112 Antibodies	Day 1 to Day 43

Collaborators and Investigators

• Sponsor: EA Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2019
• Primary Completion (ACTUAL): May 20, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Japanese; Phase 1; E3112
• Other Study ID Numbers: E3112-CP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No