Status:
COMPLETED
A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pharmacokinetics of Alefacept
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects
Eligibility Criteria
Inclusion
- Caucasian or Japanese healthy subject with a body mass index (BMI) of 18 to 29 kg/m2, inclusive
- Japanese subject is first generation, born in Japan from parents of Japanese decent, and has resided outside of Japan for 5 years or less OR Caucasian subject is Hispanic or non-Hispanic, born of parents of European decent (not Mestizo or mixed race)
- Subject must have clinical laboratory test results within the normal therapeutic range or, if abnormal, the results are not clinically significant as determined by the investigator
Exclusion
- CD4+ lymphocyte count outside normal limits at Screening
- Received vaccine within 60 days prior to study drug administration
- History of drug or alcohol abuse within the 2 years prior to the study drug administration
- Treatment with any systemic immunosuppressant agent within 6 months prior to study drug administration
- Treatment with any antibody or biologic product within 6 months prior to study drug administration
- Treatment with any systemic steroid or steroid inhaler within 2 months prior to study drug administration
- A smoking habit of greater than 10 cigarettes a day
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00653822
Start Date
March 1 2008
End Date
July 1 2008
Last Update
February 28 2013
Active Locations (1)
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1
Glendale, California, United States, 91206