Influenza Clinical Trial
Official title:
A Phase 1 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1273 and the Effect of Food on ZSP1273 Pharmacokinetics in Chinese Healthy Subjects.
This is a single center,double-blind,randomized,parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of ZSP1273,and the effect of food on ZSP1273 Pharmacokinetics.
The study will be divided in 3 parts :
Study Part I(Single Ascending Dosing, SAD) will be a single ascending dose to be run at a
maximum of 6 dose levels. Subjects included in this part of the study will receive only one
dose level to limit the exposure to ZSP1273. Four subjects are planned to be included in the
first group while 10 subjects are enrolled in every following cohort.
Study Part II(Multiple Ascending Dosing, MAD) will start after completion of some Cohorts of
Study Part I. Study Part II will be a multiple ascending dose to be run at a maximum of 3
dose levels. Subjects included in this part of the study will receive only one dose level.
This part also enrolls 10 subjects in every cohort.
Study Part III(Food Effect study, FE) will consists of 2 periods,and subjects will receive a
single dose ranged from 100-600mg on fasting and postprandial states respectively. There will
be a 7-day wash out period between treatment periods.A total of 12 to 18 subjects will be
included.
All the 3 parts will be run in healthy subjects.
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