NCT01081704

A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male 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

A study of the pharmacokinetics of ustekinumab in Chinese male subjects.

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 ustekinumab (Stelara). The study population will consist of 24 healthy male participants in China. Participants will receive a single dose of either 45mg or 90 mg ustekinumab. Participants 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 (e.g., blood pressure), and the occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ustekinumab	Single dose of 45 mg subcutaneous injection
DRUG	ustekinumab	Single dose of 90 mg subcutaneous injection

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-03-05
• Last updated: 2014-05-28

Locations

1 site across 1 country: China