This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral single and multiple dose administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
AND017 administrated as oral single-dose on Day 1 in Part A
AND017 administrated once daily from Day 1 to Day 10 in Part B
Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B
Scientia Clinical Research
Randwick, New South Wales, Australia
Safety evaluations
Incidents of AE and abnormal laboratory tests
Time frame: 17 Days
Plasma Cmax of AND017
The plasma Cmax of AND017 by single dose administration
Time frame: 1 day
Plasma Tmax of AND017
The plasma Tmax of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10
Time frame: 1 day and 10 days
Plasma t1/2 of AND017
The plasma T1/2 of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10
Time frame: 1 day and 10 days
Plasma AUC of AND017
The plasma AUCs of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10
Time frame: 1 day and 10 days
Plasma CL/F of AND017
The plasma CL/F of AND017 after single dose administration
Time frame: 1 day
Plasma Vz/F of AND017
The plasma Vz/F of AND017 after single dose administration
Time frame: 1 day
Plasma MRT of AND017
The plasma MRT of AND017 after single dose administration
Time frame: 1 day
Plasma λz of AND017
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The plasma λz of AND017 after single dose administration
Time frame: 1 day
Plasma %AUCex of AND017
The plasma %AUCex of AND017 after single dose administration
Time frame: 1 day
Plasma Css,min of AND017
The plasma Css,min of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
Plasma Css,max of AND017
The plasma Css,max of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
Plasma Css,avg of AND017
The plasma Css,avg of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
Plasma CLss/F of AND017
The plasma CLss/F of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
Plasma Vss/F of AND017
The plasma Vss/F of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
Plasma Rac(AUC) of AND017
The plasma Rac(AUC) of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
Plasma DF of AND017
The plasma DF of AND017 by multiple administration for 10 consecutive days
Time frame: 10 days
PD parameters
Change from baseline levels of EPO
Time frame: 17 days
PD parameters
Change from baseline levels of HB
Time frame: 17 days
PD parameters
Change from baseline levels of RET
Time frame: 17 days