Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30mg, 60mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort. This study includes an 28-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Peking Union Medical College Hospital
Beijing, China
RECRUITINGNumber of adverse events and serious adverse events.
Time frame: Day1 up to Day20±3
Cmax
Maximum observed plasma concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
area under the curve from time zero to the last quantifiable concentration
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
area under the curve from time zero extrapolated to infinity
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
t1/2
Terminal elimination half-life
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
clearance CL/F
Apparent total plasma clearance
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
Vz/F
Apparent total volume of distribution
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.