Expired Study
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Glendale, California 91206


Purpose:

The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00653822


Primary Contact:

Study Director
Use Central Contact
Astellas Pharma US, Inc.


Backup Contact:

N/A


Location Contact:

Glendale, California 91206
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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