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

EA Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Male Participants

Treatments: Other: Placebo; Drug: E3112

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922633

E3112-CP2

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 8 patient groups

Cohort 1 Group A: E3112 + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 1 Group B: Placebo + E3112

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 2 Group A: E3112 + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 2 Group B: Placebo + E3112

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 3 Group A: E3112 + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 3 Group B: Placebo + E3112

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 4 Group A: E3112 + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112

Cohort 4 Group B: Placebo + E3112

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: E3112