A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects

Healthy Volunteers Clinical Trial

Official title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of CNTO 148 Following Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

Clinical Trial Description

This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT01258777
• Study type: Interventional
• Source: Centocor, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Completion date: April 2011