Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults
NCT03619616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-10-23
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.
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.
Sponsors & Collaborators
-
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Guoping Yang, MD · The Third Xiangya Hospital of Central South University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-07-16
- Primary Completion
- 2019-06-28
- Completion
- 2019-10-22
Countries
- China
Study Locations
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