NCT01288157

A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

A Randomized, Open-label Study to Evaluate the Pharmacokinetics of a Single Subcutaneous Administration of 50 mg or 100 mg Golimumab in a Pre-filled Syringe Formulation to Healthy Male Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 Chinese male participants.

Detailed description

This is a randomized (study medication assigned by chance), open-label (both the physician and subject 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 participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 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 50 mg or 100 mg golimumab as a subcutaneous injection.

Conditions

• Healthy Adult Chinese Males

Interventions

Type	Name	Description
DRUG	Golimumab	Single dose of 100 mg subcutaneously
DRUG	Golimumab	Single dose of 50 mg subcutaneously

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-02-02
• Last updated: 2014-05-28

Locations

1 site across 1 country: China