A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CNTO 148 Following Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258777

Enrollment

Registered

2010-12-13

Start date

2010-10-31

Completion date

2011-04-30

Last updated

2013-09-04

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

Conditions

Healthy Volunteers

Keywords

Healthy volunteers, Japanese male, Caucasian male, Simponi

Brief summary

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

Detailed description

This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not 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 Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects 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 (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.

Interventions

DRUG400 mg golimumab or placebo

Single dose of 400 mg subcutaneously

DRUG200 mg golimumab or placebo

Single dose of 200 mg subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

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 * Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report * Japanese subjects must have a valid Japanese passport * Caucasian subjects must have Caucasian parents.

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 (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)
Determine the immune response of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)
Safety of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)
Tolerability of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)

Countries

United States

Outcome results

None listed

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