NCT03619616

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults

A Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Guangdong Zhongsheng Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603 and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally administered once daily of ZSP1603.

Detailed description

This is a Phase 1, double-blinded, placebo-controlled, single center study aimed at investigating the safety, tolerability and the pharmacokinetics of ZSP1603 on fasted condition.Up to 4 cohorts of 32 eligible participants totally are planned to be enrolled. This is a two-arm clinical trial that ZSP1603 and matching placebo will be orally administered once daily. Two subjects in the first cohort will be assigned in a opened fashion to receive 7.5mg of ZSP1603 while another three cohorts of volunteers will be randomly assigned in a blinded fashion to receive either a single dose of ZSP1603 or matching placebo in an ascending dose fashion. To monitor AEs,record abnormalities (Holter, 12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of ZSP1603.

Conditions

• Idiopathic Pulmonary Fibrosis(IPF)
• Solid Tumor

Interventions

Type	Name	Description
DRUG	ZSP1603 7.5 mg	ZSP1603 capsule administered orally once daily under fasted condition.
DRUG	ZSP1603 12.5 mg	ZSP1603 capsule administered orally once daily in the fasting state.
DRUG	Placebo 12.5mg	Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.
DRUG	ZSP1603 25 mg	ZSP1603 capsule administered orally once daily under fasted condition.
DRUG	Placebo 25mg	Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
DRUG	ZSP1603 50 mg	ZSP1603 capsule administered orally once daily under fasted state.
DRUG	Placebo 50mg	Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.

Timeline

• Start date: 2018-07-16
• Primary completion: 2019-06-28
• Completion: 2019-10-22
• First posted: 2018-08-08
• Last updated: 2019-10-23

Locations

1 site across 1 country: China