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

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.

Conditions

• Influenza

Interventions

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.

Sponsors & Collaborators

• Guangdong Zhongsheng Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yanhua Ding, MD · The First Hospital of Jilin University

• Shucheng Hua, MD · The First Hospital of Jilin University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-20

Primary Completion

2019-03-19

Completion

2019-04-26

Countries

• China

Study Locations