Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients
Study identifier:D4430C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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)
Medical condition
Rheumatoid Arthritis
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
39
Study type
Interventional
Age
20 Years - 75 Years
Date
Study Start Date: 01 May 2012
Primary Completion Date: 01 Feb 2014
Study Completion Date: 01 Feb 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Feb 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Joel Posner
Astrazeneca, Waltham, MA, United States
