| Trial ID: | L0308 |
| Source ID: | NCT03392779
|
| Associated Drug: |
ZSP1601
|
| Title: |
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: ZSP1601 25 mg|Drug: Placebo 25mg|Drug: ZSP1601 50 mg|Drug: Placebo 50 mg|Drug: ZSP1601 100 mg|Drug: Placebo 100 mg|Drug: ZSP1601 175 mg|Drug: Placebo 175 mg|Drug: ZSP1601 275 mg|Drug: Placebo 275 mg|Drug: ZSP1601 350 mg|Drug: Placebo 350mg|Drug: Pla
|
| Outcome Measures: |
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses(single,multiple and food effect)of ZSP1601 and placebo.|Concomitant Medication|Clinical Laboratory Abnormalities(Blood routine test, serum biochemical test, conventional coagulation examinations, urine examination ) post dose of ZSP1601 and placebo.|12-lead ECG Abnormalities following oral dosing of ZSP1601 and placebo.|Vital signs Abnormalities following oral dosing of ZSP1601 and placebo.|Physical examination Abnormalities following oral dossing of ZSP1601 and placebo.|Cardiac color ultrasound(UCG) Abnormalities following multiple oral doses of ZSP1601 and placebo.|AUClast???AUC0-t???of ZSP1601|AUCinf???AUC0-??????of ZSP1601|Cmax of ZSP1601|Tmax of ZSP1601|t1/2z of ZSP1601|Single-dose PK Parameter: Ae of ZSP1601|Single-dose PK Parameter: Fe0-t of ZSP1601|CL/F of ZSP1601|??z of ZSP1601|CLr of ZSP1601|Multiple-dose plasma PK parameter: Rac of ZSP1601 at steady state|Multiple-dose plasma PK parameter: DF of ZSP1601 at steady state|Multiple-dose plasma PK parameter: Cmin of ZSP1601 at steady state
|
| Sponsor/Collaborators: |
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
|
| Gender: |
All
|
| Age: |
18 Years to 50 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
94
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
January 5, 2018
|
| Completion Date: |
March 22, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 13, 2019
|
| Locations: |
The First Hospital of Jilin University, Changchun, Jilin, China
|
| URL: |
https://ClinicalTrials.gov/show/NCT03392779
|
