A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

Centocor, Inc.24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ustekinumabDRUG

Single dose of 45 mg subcutaneous injection

ustekinumabDRUG

Single dose of 90 mg subcutaneous injection

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Have no clinically relevant abnormalities * Non smoker Exclusion Criteria: * Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease * Have any underlying physical or psychological medical condition * Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.

Time frame: Week 16

Secondary Outcomes

Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events

Time frame: Week 16

Immune response (immunogenicity) of ustekinumab

Time frame: Week 16

Data from ClinicalTrials.gov

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