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Completed

NCT Number: NCT00653822

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

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

Completed

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alefacept

Drug

IC and SC

Other names: Amevive, ASP0485

Placebo

Drug

IV and SC

Primary outcomes

  1. Serum alefacept pharmacokinetic parameters

    Time frame: Days 1-8,15, 22, 29 and 43

Secondary outcomes

  1. Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets

    Time frame: Days 1-8, 15, 22, 29 and 43

  2. Safety variables including anti-alefacept antibodies

    Time frame: Days 1-8, 15, 22, 29 and 43

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 7, 2008
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.