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

NCT03014895 | Completed Early Phase 1

• 1 other identifier: E3112/CP1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Male Volunteers

Keywords

E3112; Pharmacokinetics; Japanese

Outcome Measures

Primary Outcomes (6)

• 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.

  Days 1 to 4, 8, 14, and 28

• 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.

  Days 1 to 4, 8, 14, and 28

• Area under the curve (AUC)

  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.

  Days 1 to 4, 8, 14, and 28

• 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.

  Days 1 to 4, 8, 14, and 28

• Clearance of E3112

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

  Days 1 to 4, 8, 14, and 28

• 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.

  Days 1 to 4, 8, 14, and 28

Secondary Outcomes (7)

• Number of participants with any serious adverse event and any non-serious adverse event

  Days 1 to 28

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

  Days 1 to 28

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

  Days 1 to 28

• Number of participants with an abnormal, clinically significant urine value

  Days 1 to 28

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

  Baseline; Days 1 to 28

Study Arms (10)

Cohort 1: Placebo

PLACEBO COMPARATOR

Intravenous placebo infusion

Drug: Placebo

Cohort 1: E3112

EXPERIMENTAL

Intravenous E3112 infusion

Drug: E3112

Cohort 2: Placebo

PLACEBO COMPARATOR

Intravenous placebo infusion

Drug: Placebo

Cohort 2: E3112

EXPERIMENTAL

Intravenous E3112 infusion

Drug: E3112

Cohort 3: Placebo

PLACEBO COMPARATOR

Intravenous placebo infusion

Drug: Placebo

Cohort 3: E3112

EXPERIMENTAL

Intravenous E3112 infusion

Drug: E3112

Cohort 4: Placebo

PLACEBO COMPARATOR

Intravenous placebo infusion

Drug: Placebo

Cohort 4: E3112

EXPERIMENTAL

Intravenous E3112 infusion

Drug: E3112

Cohort 5: Placebo

PLACEBO COMPARATOR

Intravenous placebo infusion

Drug: Placebo

Cohort 5: E3112

EXPERIMENTAL

Intravenous E3112 infusion

Drug: E3112

Interventions

Placebo DRUG

Intravenous infusion

Cohort 1: Placebo; Cohort 2: Placebo; Cohort 3: Placebo; Cohort 4: Placebo; Cohort 5: Placebo

E3112 DRUG

Intravenous infusion

Cohort 1: E3112; Cohort 2: E3112; Cohort 3: E3112; Cohort 4: E3112; Cohort 5: E3112

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (1)

EA Pharma Trial Site

Toshima City, Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 9, 2017
• Study Start: January 25, 2017
• Primary Completion: June 12, 2017
• Study Completion: November 22, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)