A Phase 2a study of PORT-77 in adults with erythropoietic protoporphyria (EPP)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
Celerion
Tempe, Arizona, United States
Plasma PPIX level
Change over the course of the study in plasma PPIX concentrations
Time frame: 9 Days
Evaluate safety and tolerability of 2 different dose regimens of PORT-77
Safety and tolerability over the course of the study, as assessed by adverse events (AEs) and laboratory results
Time frame: 9 Days
Cmax
Maximum measured concentration of PORT-77 in plasma (Cmax).
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12 hours post dose
Tmax
Time from dosing to maximum measured concentration of PORT-77 in plasma
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12 hours post dose
AUC0-last
Area under the concentration-time curve of of PORT-77 in plasma over the time interval from 0 to the time of the last quantifiable data point.
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12 hours post dose
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