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

EA Pharma

Status and phase: Completed; Early Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Placebo; Drug: E3112

Study type: Interventional

Funder types: Industry

Identifiers

NCT03014895

E3112/CP1

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 10 patient groups, including a placebo group

Cohort 1: Placebo

Placebo Comparator group

Description:

Intravenous placebo infusion

Treatment:

Drug: Placebo

Cohort 1: E3112

Experimental group

Description:

Intravenous E3112 infusion

Treatment:

Drug: E3112

Cohort 2: Placebo

Placebo Comparator group

Description:

Intravenous placebo infusion

Treatment:

Drug: Placebo

Cohort 2: E3112

Experimental group

Description:

Intravenous E3112 infusion

Treatment:

Drug: E3112

Cohort 3: Placebo

Placebo Comparator group

Description:

Intravenous placebo infusion

Treatment:

Drug: Placebo

Cohort 3: E3112

Experimental group

Description:

Intravenous E3112 infusion

Treatment:

Drug: E3112

Cohort 4: Placebo

Placebo Comparator group

Description:

Intravenous placebo infusion

Treatment:

Drug: Placebo

Cohort 4: E3112

Experimental group

Description:

Intravenous E3112 infusion

Treatment:

Drug: E3112

Cohort 5: Placebo

Placebo Comparator group

Description:

Intravenous placebo infusion

Treatment:

Drug: Placebo

Cohort 5: E3112

Experimental group

Description:

Intravenous E3112 infusion

Treatment:

Drug: E3112