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
-To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.
-The primary objective of the study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | MEDI 545 |
|
| 2 | Placebo Comparator | Placebo IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI 545 | Biological | IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126. | Through day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints are the PK and IM of single-dose IV MEDI-545. | determination not stated |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara White, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research, Laval, Inc. | Laval-Quebec | H7S 2C5 | Canada | |||
| Innovaderm Research, Inc. |
Not provided
| ID | Term |
|---|---|
| C568334 | sifalimumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg |
|
| Montreal |
| H2K 4L5 |
| Canada |
| Probity Medical Research | Waterloo- Ontario | N2J 1C4 | Canada |