A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Centocor Ortho Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy Adult Chinese Males

Treatments

Drug: Golimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01288157

C0524T30

CR016273

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.