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

NCT04137055 ↗

Phase 1 Completed 104 enrolled Guangdong Raynovent Biotech Co., Ltd
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

EvaluationDrugModalityDoseRoute
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