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
No locations available
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. |