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

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of Alefacept

Treatments: Drug: alefacept; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653822

0485-CL-J101

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

75 participants in 6 patient groups, including a placebo group

1a

Experimental group

Description:

IV

Treatment:

Drug: alefacept

1b

Placebo Comparator group

Description:

IV

Treatment:

Drug: placebo

2a

Experimental group

Description:

Lower SC dose

Treatment:

Drug: alefacept

2b

Placebo Comparator group

Description:

SC to match lower dose

Treatment:

Drug: placebo

3a

Experimental group

Description:

Higher SC dose

Treatment:

Drug: alefacept

3b

Placebo Comparator group

Description:

SC to match higher dose

Treatment:

Drug: placebo