| Trial ID: | L0237 |
| Source ID: | NCT04140123
|
| Associated Drug: |
ZSP1601
|
| Title: |
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: ZSP1601|Drug: ZSP1601 Placebo
|
| Outcome Measures: |
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.|MRI-PDFF|TNF-??|ALT|AST|Tmax|Cmax|t1/2z|Rac of Cmax|DF of ZSP1601 at steady status|AUClast???AUC0-t???|Rac of AUC
|
| Sponsor/Collaborators: |
Guangdong Raynovent Biotech Co., Ltd
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1/Phase 2
|
| Enrollment: |
37
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
June 23, 2020
|
| Completion Date: |
August 3, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 11, 2021
|
| Locations: |
The First Hospital of Jilin University, Changchun, Jilin, China
|
| URL: |
https://ClinicalTrials.gov/show/NCT04140123
|
