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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 16, 2018

Primary Completion Date

June 28, 2019

Study Completion Date

October 22, 2019

Conditions
Idiopathic Pulmonary Fibrosis(IPF)Solid Tumor
Interventions
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.

Trial Locations (1)

410013

The Third Xiangya Hospital of Central South University, Changsha

All Listed Sponsors
lead

Guangdong Zhongsheng Pharmaceutical Co., Ltd.

INDUSTRY

NCT03619616 - Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults | Biotech Hunter | Biotech Hunter