A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers
NCT ID: NCT00653822
Last Updated: 2013-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2008-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1a
IV
alefacept
IC and SC
1b
IV
placebo
IV and SC
2a
Lower SC dose
alefacept
IC and SC
2b
SC to match lower dose
placebo
IV and SC
3a
Higher SC dose
alefacept
IC and SC
3b
SC to match higher dose
placebo
IV and SC
Interventions
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alefacept
IC and SC
placebo
IV and SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
65 Years
ALL
Yes
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Glendale, California, United States
Countries
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Other Identifiers
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0485-CL-J101
Identifier Type: -
Identifier Source: org_study_id