A phase 1, single-dose study of E6011 in Japanese healthy adult subjects
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080221973
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 64
1. Non-smoking Japanese males aged between 20 and 44 years old,
2. BMI at screening is between 18.5 kg/m2 and <25.0 kg/m2,
3. Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period.
1. Has been treated with biologic products (except for immunoglobulin preparation),
2. Have received immunoglobulin or blood preparation within 6 months before the study drug administration,
3. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis,
4. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis abliterate,
5. With gross hematuria, occult bleeding in urine (greater than or equal to 1+) and urine protein (greater than or equal to 1+), or either of greater than or equal to 2+ at screnning,
6.Has a clinically significant vasculitis (e.g., multiple mononeuropathy),
7. Known to be positive for human immunodeficiency virus (HIV antigen and antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (NBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or syphilis serology test,
8. Known to be positive for QuantiFERON-TB Gold Test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method