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| ID | Type | Description | Link |
|---|---|---|---|
| C0524T30 |
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The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Golimumab Single dose of 50 mg subcutaneously |
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| 002 | Experimental | Golimumab Single dose of 100 mg subcutaneously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | Single dose of 100 mg subcutaneously |
| |
| Golimumab |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Day 71 | |
| Immunogenicity of golimumab, as measured by antibodies to golimumab | Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China |
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| ID | Term |
|---|---|
| C529000 | golimumab |
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| Drug |
Single dose of 50 mg subcutaneously |
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