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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1a | Experimental | IV |
|
| 1b | Placebo Comparator | IV |
|
| 2a | Experimental | Lower SC dose |
|
| 2b | Placebo Comparator | SC to match lower dose |
|
| 3a | Experimental | Higher SC dose |
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| 3b | Placebo Comparator | SC to match higher dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alefacept | Drug | IC and SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum alefacept pharmacokinetic parameters | Days 1-8,15, 22, 29 and 43 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D000077944 | Alefacept |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| placebo | Drug | IV and SC |
|
| D002241 |
| Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |