This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either ZSP0678 or placebo .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
ZSP0678 tablet administered orally under fasted condition
ZSP0678 tablets administered orally under fasted condition
ZSP0678 tablets administered orally under fasted condition
ZSP0678 tablets administered orally under fasted condition
ZSP0678 tablets administered orally under fasted condition
ZSP0678 tablets administered orally under fasted condition
ZSP0678 tablets administered orally under fasted condition
ZSP0678 tablets administered orally under fasted or fed condition
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678 tablets administered orally once daily for 14 Days
Participants will receive placebo matching to ZSP0678 orally.
Beijing Friendship Hospital Affiliated to Capital Medical Universit
Beijing, Beijing Municipality, China
Number and severity of adverse events (AEs) and Serious Adverse Events(SAE) following oral doses of ZSP0678 and placebo.
Time frame: SAD Group: Up to 5 days, MAD: Up to 18 days, FE group: Up to11 days after first dose ]
Tmax
The time after dosing when Cmax occurs
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
Cmax
Maximum concentration
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
t1/2
t1/2 is defined as the time to decline half of the drug concentration in plasma.
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
AUCinf(AUC0-∞)
Area under the curve extrapolated until time is infinity (AUCinf)
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
AUClast(AUC0-t)
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
CL/F
CL/F is defined as the ratio of total clearance(Cl) to bioavailability(F).
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
λz
λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
CLr
CLr is defined as how many milliliters of plasma in which some substance can be completely eliminated in the unit time (per minute) of two kidneys.
Time frame: UP to 5, 18, 11 days for SAD, MAD, FE part respectively
Multiple-dose plasma PK parameter: Rac of ZSP0678 at steady state
Rac (Accumulation Index) is defined as the ratio between AUC0-XX in Day XX and AUC0-XX in Day1
Time frame: UP to 18 days.
Multiple-dose plasma PK parameter: DF of ZSP0678 at steady state
DF is defined as the percentage of fluctuation in steady state is 100 \* (Cmax, ss - Cmin, ss)/Cavg, ss.
Time frame: UP to 18 days.
Multiple-dose plasma PK parameter: Cmin of ZSP0678 at steady state
Cmin is defined as the minimum observed concentration of drug in plasma at steady state.
Time frame: UP to 18 days.
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