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

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

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Dose Study to Assess the Tolerability, Safety, and Pharmacokinetics of Alefacept in Caucasian and Japanese Healthy Volunteers

Conditions
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Pharmacokinetics of Alefacept

Intervention / Treatment
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* Drug: alefacept
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1a<br>IV | Drug: alefacept<br>* IC and SC<br>* Other names: ASP0485;|
| Placebo Comparator: 1b<br>IV | Drug: placebo<br>* IV and SC<br>|
| Experimental: 2a<br>Lower SC dose | Drug: alefacept<br>* IC and SC<br>* Other names: ASP0485;|
| Placebo Comparator: 2b<br>SC to match lower dose | Drug: placebo<br>* IV and SC<br>|
| Experimental: 3a<br>Higher SC dose | Drug: alefacept<br>* IC and SC<br>* Other names: ASP0485;|
| Placebo Comparator: 3b<br>SC to match higher dose | Drug: placebo<br>* IV and SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum alefacept pharmacokinetic parameters |  | Days 1-8,15, 22, 29 and 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amevive, alefacept, pharmacokinetics, Japanese