NCT04137055

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

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP0678 and the Effect of Food on ZSP0678 Pharmacokinetics in Chinese Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Guangdong Raynovent Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 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 ZSP0678 or placebo .

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-19
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2019-10-23
• Last updated: 2021-07-28

Locations

1 site across 1 country: China