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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653822

Enrollment

Registered

2008-04-07

Start date

2008-03-31

Completion date

2008-07-31

Last updated

2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics of Alefacept

Keywords

Amevive, alefacept, pharmacokinetics, Japanese

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

Interventions

DRUGalefacept

IC and SC

DRUGplacebo

IV and SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Serum alefacept pharmacokinetic parameters	Days 1-8,15, 22, 29 and 43

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026