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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2008

Interventions

  • Drug: alefacept
    • IC and SC
  • Drug: placebo
    • IV and SC

Arms, Groups and Cohorts

  • Experimental: 1a
    • IV
  • Placebo Comparator: 1b
    • IV
  • Experimental: 2a
    • Lower SC dose
  • Placebo Comparator: 2b
    • SC to match lower dose
  • Experimental: 3a
    • Higher SC dose
  • Placebo Comparator: 3b
    • SC to match higher dose

Clinical Trial Outcome Measures

Primary Measures

  • Serum alefacept pharmacokinetic parameters
    • Time Frame: Days 1-8,15, 22, 29 and 43

Secondary Measures

  • Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets
    • Time Frame: Days 1-8, 15, 22, 29 and 43
  • Safety variables including anti-alefacept antibodies
    • Time Frame: Days 1-8, 15, 22, 29 and 43

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Use Central Contact, Study Director, Astellas Pharma US, Inc.

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