NCT03679143

The Safety, Tolerability and Pharmacokinetic Study of ZSP1273 in Healthy Volunteers.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Guangdong Zhongsheng Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	ZSP1273 100 mg	ZSP1273 tablet administered orally once daily under fasted condition
DRUG	Placebo 100 mg	Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state.
DRUG	ZSP1273 200 mg	ZSP1273 tablets administered orally once daily under fasted condition
DRUG	Placebo 200 mg	Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
DRUG	ZSP1273 400 mg	ZSP1273 tablets administered orally once daily in the fasting state
DRUG	Placebo 400 mg	Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state
DRUG	ZSP1273 600 mg	ZSP1273 tablets administered orally once daily under fasted condition
DRUG	Placebo 600 mg	Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
DRUG	ZSP1273 900 mg	ZSP1273 tablets administered orally once daily in the fasting state
DRUG	Placebo 900 mg	Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
DRUG	ZSP1273 1200 mg	ZSP1273 tablets administered orally once daily in the fasting state
DRUG	Placebo 1200 mg	Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state
DRUG	ZSP1273	ZSP1273 tablets administered orally once daily under fasted or fed condition
DRUG	Placebo	Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition
DRUG	ZSP1273 Low Dose	ZSP1273 tablets administered orally once daily under fasted or fed condition for 5 Days.
DRUG	Placebo	Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition for 5 Days.
DRUG	ZSP1273 Median Dose	ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
DRUG	Placebo	Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
DRUG	ZSP1273 High Dose	ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
DRUG	Placebo	Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.

Timeline

• Start date: 2018-09-20
• Primary completion: 2019-03-19
• Completion: 2019-04-26
• First posted: 2018-09-20
• Last updated: 2019-08-14

Locations

1 site across 1 country: China