The Safety, Tolerability and Pharmacokinetic Study of ZSP1273 in Healthy Volunteers.
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): ZSP1273 100 mg; Placebo 100 mg; ZSP1273 200 mg; Placebo 200 mg; ZSP1273 400 mg; Placebo 400 mg; ZSP1273 600 mg; Placebo 600 mg; ZSP1273 900 mg; Placebo 900 mg; ZSP1273 1200 mg; Placebo 1200 mg; ZSP1273; Placebo; ZSP1273 Low Dose; Placebo; ZSP1273 Median Dose; Placebo; ZSP1273 High Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ZSP1273 tablet administered orally once daily under fasted condition; Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state.; ZSP1273 tablets administered orally once daily under fasted condition; Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition; ZSP1273 tablets administered orally once daily in the fasting state; Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state; ZSP1273 tablets administered orally once daily under fasted condition; Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition; ZSP1273 tablets administered orally once daily in the fasting state; Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition; ZSP1273 tablets administered orally once daily in the fasting state; Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state; ZSP1273 tablets administered orally once daily under fasted or fed condition; Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition; ZSP1273 tablets administered orally once daily under fasted or fed condition for 5 Days.; Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition for 5 Days.; ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.; Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.; ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.; Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment