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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006219-19 | EudraCT Number |
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The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lowest dose of PG110 | Experimental | single, slow intravenous infusion |
|
| Second dose of PG110 | Experimental | single, slow intravenous infusion |
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| Third dose of PG110 | Experimental | single, slow intravenous infusion |
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| Fourth dose of PG110 | Experimental | single, slow intravenous infusion |
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| Fifth dose of PG110 | Experimental | single, slow intravenous infusion |
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| Top dose of PG110 | Experimental | single, slow intravenous infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG110 | Biological | Single, slow intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of adverse events | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal elimination half-life | Three months | |
| Dose proportionality of the area under the serum concentration-time curve | Three months | |
| Pain in the index knee |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Hall, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 51568 | Utrecht | 3584 CJ | Netherlands |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Experimental | single, slow intravenous infusion that matches PG110 in appearance |
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| Seventh Dose of PG110 | Experimental | single, slow intravenous infusion |
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| Eight Dose of PG110 | Experimental | single, slow intravenous infusion |
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| PG110 |
| Biological |
Single, slow intravenous infusion |
|
| PG110 | Biological | Single, slow intravenous infusion |
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| PG110 | Biological | Single, slow intravenous infusion |
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| PG110 | Biological | Single, slow intravenous infusion |
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| PG110 | Biological | Single, slow intravenous infusion |
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| PG110 | Biological | Single, slow intravenous infusion |
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| PG110 | Biological | Single, slow intravenous infusion |
|
| Placebo | Biological | Single, slow intravenous infusion that matches PG110 in appearance |
|
| Three months |
| Western Ontario and McMaster Universities questionnaire | Three months |
| D012216 |
| Rheumatic Diseases |