A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Pharmacokinetics of Alefacept

In brief

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

Key facts

Study ID: NCT00653822
Run by: Astellas Pharma Inc
People needed: 75
Starts: 2008-03-01
Expected to finish: 2008-07-01
Last updated by the study team: 2013-02-28

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

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