A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers
- Registration Number
- NCT00653822
- Lead Sponsor
- Astellas Pharma Inc
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1a alefacept IV 1b placebo IV 2a alefacept Lower SC dose 2b placebo SC to match lower dose 3a alefacept Higher SC dose 3b placebo SC to match higher dose
- Primary Outcome Measures
Name Time Method Serum alefacept pharmacokinetic parameters Days 1-8,15, 22, 29 and 43
- Secondary Outcome Measures
Name Time Method Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets Days 1-8, 15, 22, 29 and 43 Safety variables including anti-alefacept antibodies Days 1-8, 15, 22, 29 and 43