Study identifier:MI-CP209
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
Lupus Erythematosus, Systemic
Phase 1
No
-
All
44
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2014 by MedImmune, LLC
MedImmune, LLC
AstraZeneca
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
Location
Location
Ft. Lauderdale, FL, United States
Location
London, ON, Canada
Location
San Leandro, CA, United States
Location
New York, NY, United States
Location
Atlanta, GA, United States
Location
Columbus, OH, United States
Location
Long Beach, CA, United States
Location
Ocala, FL, United States
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. | Other: Placebo A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. |
Experimental: MEDI-570 0.03 MG A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. | Biological/Vaccine: MEDI-570 0.03 MG A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. |
Experimental: MEDI-570 0.1 MG A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. | Biological/Vaccine: MEDI-570 0.1 MG A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
Experimental: MEDI-570 0.3 MG A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. | Biological/Vaccine: MEDI-570 0.3 MG A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
Experimental: MEDI-570 1 MG A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. | Biological/Vaccine: MEDI-570 1 MG A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.