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Amended clinical development plan.
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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-578 | Drug | intravenous infusion, once |
| |
| Placebo for MEDI-578 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, vital signs, ECG, safety lab) | Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of MEDI-578 in plasma. | Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12. | |
| To assess the immunogenicity of MEDI-578 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Karlsten | AstraZeneca RD Södertälje | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London Bridge | Greater London | United Kingdom |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Drug |
Intravenous infusion, once |
|
| Blood samples taken fortnightly from Day 1 until week 12. |
| To evaluate the analgesic efficacy of MEDI-578 during the night and day. | Patients will record their pain intensity every morning and evening during the 13 weeks study period. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |