Randomized, double-blind, placebo-controlled study of RSS0393 ointment in healthy and psoriatic subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
RSS0393 ointment;RSS0393 ointment placebo
The First Affiliated Hospital of University of Science and Technology of China (USTC).
Hefei, Anhui, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The percent of Local skin tolerance was assessed as moderate or higher(Single dose in healthy subjects)
Time frame: 0.5, 2, 4, 12 post -dose day 1, day 2, day 3, day 5, and day 8
The percent of Local skin tolerance was assessed as moderate or higher (Multiple dose in healthy subjects)
Time frame: 0.5, 2, 4, 12 post-dose day 1, 0.5post-dose on day2、day3、day4、day5、day6, 0.5, 2, 4, 12 post-dose day7, day8, day9, day11, day14
Measurement of blood examination(Multiple dose in patients )
Time frame: Day 1, day 28, day 42 post-dose
Measurement of urine examination(Multiple dose in patients )
Time frame: Day 1, day 28, day 42 post-dose
Measurement of Blood Chemistry examination(Multiple dose in patients )
Time frame: Day 1, day 28, day 42 post-dose
Measurement of coagulation function examination(Multiple dose in patients )
Time frame: Day 1, day 28, day 42 post-dose
AUC0-t (Single dose in healthy subjects)
Time frame: pre-dose,1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
AUC0-∞(Single dose in healthy subjects)
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Tmax(Single dose in healthy subjects)
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Cmax(Single dose in healthy subjects)
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Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
t1/2(Single dose in healthy subjects)
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
CL/F(Single dose in healthy subjects)
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Vz/F(Single dose in healthy subjects)
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
AUC0-t (Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
AUC0-∞(Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Tmax(Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Cmax(Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
t1/2(Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
CL/F(Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Vz/F(Multiple dose in healthy subjects)
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Absolute change in PASI score relative to baseline(Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage change in PASI score relative to baseline((Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage of PASI50、PASI75、PASI90、PASI100(Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline (Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage of subjects' inPGA score improvement ≥ 2 from baseline(Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
Absolute change in BSA score relative to baseline(Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage change in BSA score relative to baseline(Multiple dose in patients )
Time frame: Day 7, Day 14, Day 28 post-dose
Pharmacokinetics (PK) : Concentrations of RSS0393(Multiple dose in patients )
Time frame: Day1 ,Day 7, day 14, Day 28
Pharmacokinetics (PK) : The major metabolites of RSS0393(Multiple dose in patients )
Time frame: Day1 ,Day 7, day 14, Day 28