A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers
The purpose of this study is to evaluate the safety, tolerability and how the body affects the drug CNTO 136 in healthy Japanese and Caucasian volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of CNTO136 Following a Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects.|
- Safety and tolerability of a single SC administration of CNTO 136 in healthy Japanese and Caucasian volunteers
- Pharmacokinetics and immunogenicity of a single SC administration of CNTO 136.
|Study Start Date:||January 2009|
|Study Completion Date:||August 2009|
This is a randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of CNTO 136. In a randomized trial, study medication (CNTO 136 or placebo) is assigned by chance. Double-blinded means that neither the investigator nor the volunteer know which of the study medication they have been assigned to receive. Pharmacokinetics is the study of levels of CNTO 136 circulating in your blood over time. The study population will all be male and consist of 30 Japanese and 30 Caucasian volunteers. Three dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then required to return for out-patient visits. One of 3 dose levels of CNTO 136 will be given just under the skin (subcutaneous (SC)). The length of this study will be about 20 weeks.