| Trial ID: | L0291 |
| Source ID: | NCT04137055
|
| Associated Drug: |
ZSP0678
|
| Title: |
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: ZSP0678-10mg|Drug: ZSP0678-30mg|Drug: ZSP0678-60mg|Drug: ZSP0678-120mg|Drug: ZSP0678-180mg|Drug: ZSP0678-240mg|Drug: ZSP0678-320mg|Drug: ZSP0678|Drug: ZSP0678-Dose 1|Drug: ZSP0678-Dose 2|Drug: ZSP0678-Dose 3|Drug: ZSP0678 Placebo
|
| Outcome Measures: |
Number and severity of adverse events (AEs) and Serious Adverse Events(SAE) following oral doses of ZSP0678 and placebo.|Tmax|Cmax|t1/2|AUCinf???AUC0-??????|AUClast???AUC0-t???|CL/F|??z|CLr|Multiple-dose plasma PK parameter: Rac of ZSP0678 at steady state|Multiple-dose plasma PK parameter: DF of ZSP0678 at steady state|Multiple-dose plasma PK parameter: Cmin of ZSP0678 at steady state
|
| Sponsor/Collaborators: |
Guangdong Raynovent Biotech Co., Ltd
|
| Gender: |
All
|
| Age: |
18 Years to 50 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
104
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
November 19, 2019
|
| Completion Date: |
December 9, 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
July 28, 2021
|
| Locations: |
Beijing Friendship Hospital Affiliated to Capital Medical Universit, Beijing, Beijing, China
|
| URL: |
https://ClinicalTrials.gov/show/NCT04137055
|
