A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Adult Chinese Males

Intervention / Treatment
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* Drug: Golimumab
* Drug: Golimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Golimumab Single dose of 50 mg subcutaneously | Drug: Golimumab<br>* Single dose of 50 mg subcutaneously<br>|
| Experimental: 002<br>Golimumab Single dose of 100 mg subcutaneously | Drug: Golimumab<br>* Single dose of 100 mg subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Day 71 | 
| Immunogenicity of golimumab, as measured by antibodies to golimumab |  | Day 71 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, adult, Chinese, male, Simponi, CNTO 148