drugset / Trial / NCT04137055
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
RandomizedSequentialQuadruple-blindTreatment
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 .
Timeline
- Start
- 2019-11-19
- Primary completion
- 2020-12-09
- Completion
- 2020-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZSP0678 | Unknown | 10 mg | Oral |
| Subject | ZSP0678 | Unknown | 30 mg | Oral |
| Subject | ZSP0678 | Unknown | 60 mg | Oral |
| Subject | ZSP0678 | Unknown | 120 mg | Oral |
| Subject | ZSP0678 | Unknown | 180 mg | Oral |
| Subject | ZSP0678 | Unknown | 240 mg | Oral |
| Subject | ZSP0678 | Unknown | 320 mg | Oral |