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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288157

Enrollment

Registered

2011-02-02

Start date

2010-09-30

Completion date

2011-01-31

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 Adult Chinese Males

Keywords

healthy, adult, Chinese, male, Simponi, CNTO 148

Brief 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.

Interventions

DRUGGolimumab

Single dose of 100 mg subcutaneously

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 or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.

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
Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects	Day 71 (Week 11)

Secondary

Measure	Time frame
Number of participants with adverse events	Day 71
Immunogenicity of golimumab, as measured by antibodies to golimumab	Day 71

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026