NCT03392779

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

A Phase 1 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1601 and the Effect of Food on ZSP1601 Pharmacokinetics in Chinese Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Guangdong Zhongsheng Pharmaceutical 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 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 .

Detailed description

The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics part.The primary aims of the study as below: Evaluating the safety and tolerance of single and multiple dose of ZSP1601 in healthy volunteers. Evaluating the fasting and postprandial pharmacokinetic parameters of ZSP1601 in healthy volunteers. Eligible participants will be admitted to the trial center on Day -1. Subjects will be randomly assigned to either experimental groups or placebo groups, according to a randomisation schedule in a (4:1) ratio (8 in per experimental group). Subjects in SAD will receive 25、50、100、175、275、350 mg once daily respectively.Each dose will be administrated after assurance of safety for the former dose. Subjects in MAD will receive 50 or 100 mg once daily for 14days respectively.The treatment in food effect consists of 2 periods,and subjects will receive 100mg on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods.To monitor AEs,record abnormalities (12-lead ECG,Vital signs,Physical examination,Clinical Laboratory),and detect the pharmacokinetics of ZSP1601.

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-01-05
• Primary completion: 2018-12-21
• Completion: 2019-03-22
• First posted: 2018-01-08
• Last updated: 2019-08-13

Locations

1 site across 1 country: China