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A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

2014-08-27 03:15:24 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

ustekinumab, ustekinumab

Status

Completed

Source

Centocor, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:24-0400

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