Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
ZSP1601 tablets be taken orally for 28 days.
Subjects will receive matching placebo of ZSP1601
The First Hospital of Jilin University
Changchun, Jilin, China
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.
severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
Time frame: Initiation of study treatment (Day 1) up to 2 weeks post-treatment.
MRI-PDFF
liver fat content with Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame: Baseline and Day 28.
TNF-α
Tumor necrosis factor alpha level in serum
Time frame: Baseline and Day 28.
ALT
serum Alanine Aminotransferase
Time frame: Baseline and Day 28.
AST
serum Aspartate Aminotransferase
Time frame: Baseline and Day 28.
Tmax
The time after dosing when Cmax occurs (Tmax)
Time frame: Day1 and day 14
Cmax
Maximum Contentration
Time frame: Day1 and day 14
t1/2z
t1/2z is defined as the time to decline half of the drug concentration in plasma.
Time frame: Day1 and day 14
Rac of Cmax
Rac of ZSP1601 Peak Plasma Concentration at steady state
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day1 and day 14
DF of ZSP1601 at steady status
Multiple-dose plasma PK parameter: DF of ZSP1601 at steady status
Time frame: Day1 and day 14
AUClast(AUC0-t)
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Time frame: Baseline (0h) and day 14
Rac of AUC
RAC of ZSP1601 Area under the plasma concentration versus time curve at steady state
Time frame: Day1 and day 14