Status:
COMPLETED
Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
Eligibility Criteria
Inclusion
- Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
- BMI in the range of 17.6 to 26.4.
- Nonsmoker or male who smokes fewer than 10 cigarettes per day.
Exclusion
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00916110
Start Date
November 1 2008
End Date
November 1 2009
Last Update
January 16 2013
Active Locations (1)
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1
Investigational Site
Toshima City, Tokyo, Japan, 171-0014