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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo
Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
Time frame: From start of study drug administration through Day 56
Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials
Based on the occurrence of dose-limiting toxicities (through Day 14)
Time frame: From start of study drug administration through Day 56
Evaluate pharmacokinetic profile of a single dose of AMP-110
Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110
Time frame: From Day 0 pre-dose through Day 28
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