Study identifier:AMP-110-01
ClinicalTrials.gov identifier:NCT01878123
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects with Rheumatoid Arthritis
Rheumatoid Arthritis
Phase 1
No
-
All
26
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2016 by MedImmune, LLC
MedImmune, LLC
Daiichi Sankyo Co., LTD
This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.
Location
Location
Duncansville, Pennsylvania, United States, 16635
Location
Dallas, Texas, United States, 75231
Location
Anniston, Alabama, United States, 36207
Arms | Assigned Interventions |
---|---|
Experimental: AMP-110 Escalating doses of AMP-110 | Biological/Vaccine: AMP-110 Dose levels 1 through 7: Single intravenous infusion on Day 0 |
Placebo Comparator: Placebo | Other: Placebo Dose levels 4 through 7: Single intravenous infusion on Day 0 |
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