Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
NCT04137055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2021-07-28
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
Interventions
- 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.
Sponsors & Collaborators
-
Guangdong Raynovent Biotech Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-11-19
- Primary Completion
- 2020-12-09
- Completion
- 2020-12-09
Countries
- China
Study Locations
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