Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | 200 mg golimumab or placebo Single dose of 200 mg subcutaneously |
|
| 002 | Experimental | 400 mg golimumab or placebo Single dose of 400 mg subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 mg golimumab or placebo | Drug | Single dose of 400 mg subcutaneously |
| |
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 200 mg golimumab or placebo |
| Drug |
Single dose of 200 mg subcutaneously |
|