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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081704

Enrollment

Registered

2010-03-05

Start date

2009-10-31

Completion date

2010-06-30

Last updated

2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteer, Chinese male, Stelara

Brief 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.

Interventions

DRUGustekinumab

Single dose of 45 mg subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.	Week 16

Secondary

Measure	Time frame
Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events	Week 16
Immune response (immunogenicity) of ustekinumab	Week 16

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026