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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO6785OPD1001 |
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The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.
This is a randomized (study drug will be assigned by chance), double-blind (neither the volunteer, physician, or study staff will know the identity of the assigned treatment), study to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785 administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous (under the skin) administration to healthy adult volunteers.This will be the first administration of CNTO 6785 to humans; therefore, no clinical experience is available. Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3 mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg |
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| 002 | Experimental | CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg |
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| 003 | Experimental | CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg |
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| 004 | Placebo Comparator | Placebo IV A single 30-minute IV infusion of placebo |
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| 005 | Experimental | CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections |
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| 006 | Placebo Comparator | Placebo SC A single SC dose of placebo administered in up to 3 SC injections |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo IV | Drug | A single 30-minute IV infusion of placebo |
| |
| CNTO 6785 1 mg/kg IV |
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of adverse events reported | Up to Week 17 | |
| Number and type of Infusion (injection) site reactions | Up to Week 17 | |
| Vital signs measurements | Up to Week 17 | |
| Clinical laboratory test results | Up to Week 17 | |
| Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry) | Up to Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of CNTO 6785 | Up to Week 17 | |
| Serum antibodies to CNTO 6785 | Up to Week 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| Drug |
A single 30-minute IV infusion of CNTO 6785 1 mg/kg |
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| CNTO 6785 3 mg/kg IV | Drug | A single 30-minute IV infusion of CNTO 6785 3 mg/kg |
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| CNTO 6785 10 mg/kg IV | Drug | A single 30-minute IV infusion of CNTO 6785 10 mg/kg |
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| CNTO 6785 SC | Drug | A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections |
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| Placebo SC | Drug | A single SC dose of placebo administered in up to 3 SC injections |
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