Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics

Summary

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either ZSP1601 or placebo .

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).

Sponsors & Collaborators

• Guangdong Zhongsheng Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yanhua Ding, 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

2018-01-05

Primary Completion

2018-12-21

Completion

2019-03-22

Countries

• China

Study Locations