NCT03679143View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

September 20, 2018

Primary Completion Date

March 19, 2019

Study Completion Date

April 26, 2019

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.

Trial Locations (1)

130021

The First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

Guangdong Zhongsheng Pharmaceutical Co., Ltd.

INDUSTRY

NCT03679143 - The Safety, Tolerability and Pharmacokinetic Study of ZSP1273 in Healthy Volunteers. | Biotech Hunter | Biotech Hunter