Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
Placebo
WCCT Global
Cypress, California, United States
Number of treatment-emergent adverse events
Subject incidence of treatment-emergent adverse events (TEAEs), which may include changes in laboratory safety tests, electrocardiograms (ECG), and vital signs.
Time frame: From signing of informed consent through the last follow up visit (up to Day 10)
Cmax
Maximum plasma concentration during a dosing interval
Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
tmax
Time to reach maximum plasma concentration
Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
AUC(0-last)
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Ae
Amount of manganese and zinc excreted into urine
Time frame: 4 hours post-dose and 24 hours post-dose
Ae%
Percent of study drug manganese excreted into urine
Time frame: 4 hours and 24 hours post-dose
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