A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian 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 Japanese and Caucasian Males.

Detailed Description
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: 400 mg golimumab or placebo
* Drug: 200 mg golimumab or placebo


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 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.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>200 mg golimumab or placebo Single dose of 200 mg subcutaneously | Drug: 200 mg golimumab or placebo<br>* Single dose of 200 mg subcutaneously<br>|
| Experimental: 002<br>400 mg golimumab or placebo Single dose of 400 mg subcutaneously | Drug: 400 mg golimumab or placebo<br>* Single dose of 400 mg subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, Japanese male, Caucasian male, Simponi