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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Page 1 of 1 (1 locations)

1

Investigational Site

Toshima City, Tokyo, Japan, 171-0014