NCT03392779 - Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 5, 2018

Primary Completion Date

December 21, 2018

Study Completion Date

March 22, 2019

Conditions

Nonalcoholic Steatohepatitis (NASH)

Interventions

DRUG

ZSP1601 25 mg

ZSP1601 tablet administered orally once daily under fasted condition

DRUG

Placebo 25mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition

DRUG

ZSP1601 50 mg

ZSP1601 tablet administered orally once daily under fasted condition

DRUG

Placebo 50 mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition

DRUG

ZSP1601 100 mg

ZSP1601 tablets administered orally once daily in the fasting state

DRUG

Placebo 100 mg

Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state

DRUG

ZSP1601 175 mg

ZSP1601 tablets administerekd orally once daily under fasted condition

DRUG

Placebo 175 mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition

DRUG

ZSP1601 275 mg

ZSP1601 tablets administered orally once daily in the fasting state

DRUG

Placebo 275 mg

Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state

DRUG

ZSP1601 350 mg

ZSP1601 tablets administered orally once daily under fasted condition

DRUG

Placebo 350mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition

DRUG

ZSP1601 100 mg

ZSP1601 tablets administered orally once daily under fasted or fed condition

DRUG

Placebo 100mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition

DRUG

ZSP1601 50 mg

ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).

DRUG

Placebo 50 mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).

DRUG

ZSP1601 100 mg

ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).

DRUG

Placebo 100 mg

Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).

Trial Locations (1)

130021

The First Hospital of Jilin University, Changchun

All Listed Sponsors

lead

Guangdong Zhongsheng Pharmaceutical Co., Ltd.

INDUSTRY