This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Omega Research Consultants, LLC.
Orlando, Florida, United States
Arthritis Center, Inc.
Palm Harbor, Florida, United States
Arthritis Treatment Center
Frederick, Maryland, United States
Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo
Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
Time frame: From start of study drug administration through Day 112
Repeat dose pharmacokinetic parameters of AMP-110 in serum
Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
Time frame: From start of study drug administration through Day 112
Optimal dose for repeat dosing of AMP-110
Optimal dose will be determined through the occurrence of AEs, SAEs, ACR-20 and DAS-28 results, and individual AMP-110 concentrations in serum including peak and trough levels
Time frame: From start of study drug administration through Day 112
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Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States