A single intravenous dose study of E3112 in Japanese healthy adult male subjects

Not Applicable

• Conditions: Healthy Adult Subjects

• Registration Number: JPRN-jRCT2080223364
• Lead Sponsor: EA Pharma Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Main Inclusion Criteria
1. Non-smoking, Japanese male subject, age >=20 and <45 years old at the time of obtaining informed consent
2. BMI >=18.5 and <25.0 kg/m2 at Screening
3. Provide written informed consent of their free will
4. Subject who was given full explanation of all the requirements of the protocol, and are willing and able to comply with them

Exclusion Criteria

Main Exclusion Criteria
1. Subject and his partner do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
2. Subject 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
3. Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
4. Any history of surgical treatment that may affect PK profiles of study drug at Screening
5. Any suspected clinically abnormal symptom or organ impairment that requires medical treatment at Screening or Baseline
6. Receipt of vaccination within 4 weeks prior to dosing
7. History of drug or alcohol dependency or abuse
8. Intake of caffeinated beverages or food within 72 hours prior to dosing
9. Use of prescription drugs within 4 weeks prior to dosing
10. Intake of over-the-counter [OTC] medications within 2 weeks prior to dosing
11. Subject 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
12. Subject who underwent blood transfusion within 12 weeks, or who donated 400 mL or more of whole blood within 12 weeks or 200 mL or more of whole blood within 4 weeks, or who made a component donation within 2 weeks prior to dosing

Study & Design

• Study Type: Interventional
• Study Design: Not specified