Glendale, California, 91206, United States
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
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Conditions
Age range
20 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugIC and SC
Other names: Amevive, ASP0485
Placebo
DrugIV and SC
Primary outcomes
-
Serum alefacept pharmacokinetic parameters
Time frame: Days 1-8,15, 22, 29 and 43
Secondary outcomes
-
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
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.