The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603 and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally administered once daily of ZSP1603.
This is a Phase 1, double-blinded, placebo-controlled, single center study aimed at investigating the safety, tolerability and the pharmacokinetics of ZSP1603 on fasted condition.Up to 4 cohorts of 32 eligible participants totally are planned to be enrolled. This is a two-arm clinical trial that ZSP1603 and matching placebo will be orally administered once daily. Two subjects in the first cohort will be assigned in a opened fashion to receive 7.5mg of ZSP1603 while another three cohorts of volunteers will be randomly assigned in a blinded fashion to receive either a single dose of ZSP1603 or matching placebo in an ascending dose fashion. To monitor AEs,record abnormalities (Holter, 12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of ZSP1603.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
ZSP1603 capsule administered orally once daily under fasted condition.
ZSP1603 capsule administered orally once daily in the fasting state.
Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately.
Number of participants with TEAEs as assessed by CTCAE v5.0.
Time frame: At Day 6 post-dose.
AUClast(AUC0-t)of ZSP1603
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Time frame: Up to 6 days post-dose
AUC0-24 of ZSP1603
AUC0-24 is defined as the concentration of drug from zero(0) hrs to 24h (area under the plasma concentration versus time curve from zero(0) hrs to 24h).
Time frame: Up to 6 days post-dose
Cmax of ZSP1603
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Up to 6 days post-dose
Tmax of ZSP1603
Tmax is defined as the time to maximum concentration.
Time frame: Up to 6 days post-dose
t1/2 of ZSP1603
t1/2 is defined as the time to half of the drug concentration in plasma.
Time frame: Up to 6 days post-dose
CL/F of ZSP1603
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Time frame: Up to 6 days post-dose
λz of ZSP1603
λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.
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ZSP1603 capsule administered orally once daily under fasted condition.
Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
ZSP1603 capsule administered orally once daily under fasted state.
Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
Time frame: Up to 6 days post-dose
VD/F of ZSP1603
VD/F is defined as apparent volume of distribution
Time frame: Up to 6 days post-dose
MRT of ZSP1603
MRT is defined as mean residence time
Time frame: Up to 6 days post-dose