NCT01258777

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	400 mg golimumab or placebo	Single dose of 400 mg subcutaneously
DRUG	200 mg golimumab or placebo	Single dose of 200 mg subcutaneously

Timeline

• Start date: 2010-10-01
• Completion: 2011-04-01
• First posted: 2010-12-13
• Last updated: 2013-09-04

Locations

1 site across 1 country: United States