Study identifier:D4430C00001
ClinicalTrials.gov identifier:NCT01559103
EudraCT identifier:2011-005402-29
CTIS identifier:N/A
A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (anti-IL-6)
Rheumatoid Arthritis
Phase 1
No
-
All
39
Interventional
20 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients
A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (anti-IL-6)
Location
Location
Belfast, Northern Ireland
Location
Overland Park, KS, United States
Location
Berlin, Germany
Arms | Assigned Interventions |
---|---|
Experimental: MEDI5117 Intravenous infusion administered over 60 minutes | Biological/Vaccine: MEDI5117 Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg |
Placebo Comparator: MEDI5117 Placebo Intravenous infusion administered over 60 minutes | Biological/Vaccine: MEDI5117 Placebo Intravenous infusion administered over 60 minutes |
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