NCT04137055View on ClinicalTrials.gov

Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics

PHASE1CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

December 9, 2020

Study Completion Date

December 9, 2020

Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG

ZSP0678-10mg

ZSP0678 tablet administered orally under fasted condition

DRUG

ZSP0678-30mg

ZSP0678 tablets administered orally under fasted condition

DRUG

ZSP0678-60mg

ZSP0678 tablets administered orally under fasted condition

DRUG

ZSP0678-120mg

ZSP0678 tablets administered orally under fasted condition

DRUG

ZSP0678-180mg

ZSP0678 tablets administered orally under fasted condition

DRUG

ZSP0678-240mg

ZSP0678 tablets administered orally under fasted condition

DRUG

ZSP0678-320mg

ZSP0678 tablets administered orally under fasted condition

DRUG

ZSP0678

ZSP0678 tablets administered orally under fasted or fed condition

DRUG

ZSP0678-Dose 1

ZSP0678 tablets administered orally once daily for 14 Days

DRUG

ZSP0678-Dose 2

ZSP0678 tablets administered orally once daily for 14 Days

DRUG

ZSP0678-Dose 3

ZSP0678 tablets administered orally once daily for 14 Days

DRUG

ZSP0678 Placebo

Participants will receive placebo matching to ZSP0678 orally.

Trial Locations (1)

100050

Beijing Friendship Hospital Affiliated to Capital Medical Universit, Beijing

All Listed Sponsors
lead

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

NCT04137055 - Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics | Biotech Hunter | Biotech Hunter