This study is a single-center, randomized, double-blind, multiple ascending doses (MAD), placebo-controlled phase Ib/IIa clinical trial of BGT-002 Tablets in subjects with NASH to evaluate the safety, tolerability, pharmacokinetics (PK) and early pharmacodynamics (PD) of BGT-002 Tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Number of participants with adverse events
Time frame: From Day 1 to Day 56
C-QTc(Concentration-QTc)
To investigate the effect of BGT-002 on QT/QTc interval in subjects
Time frame: Day1、Day28
Cmax(Peak Concentration)
The peak concentration of BGT-002 tablets was assessed after oral administration of BGT-002
Time frame: Day1
Tmax(Time of maximum observed concentration)
Evaluate the time required for the drug to reach its maximum concentration after oral administration of BGT-002
Time frame: Day1
AUC(0-24h)(Area Under Curve)
The area under the curve was assessed 0 to 24 hours after oral administration of BGT-002
Time frame: Day1
Cmax,ss
The peak concentration at stable state was assessed after oral administration of BGT-002
Time frame: Day28
Tmax,ss
The peak time at stable state was assessed after oral administration of BGT-002
Time frame: Day28
AUCss
The area under the curve at stable state after the subject's oral administration of BGT-002 was assessed
Time frame: Day28
CLss/F(Steady-State Clearance/bioavailability,F)
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The clearance rate at stalbe state was assessed after oral administration of BGT-002
Time frame: Day28
Cmin,ss
Assess valley concentrations at stable state after oral administration of BGT-002
Time frame: Day28
Rac(Accumulation Ratio)
Assess the drug accumulation index after oral administration of BGT-002
Time frame: Day28
MRI-PDFF(Magnetic resonance imaging-derived proton density fat fraction)
Assess the changes of magnetic resonance imaging derived proton density fat fraction after oral administration of BGT-002
Time frame: Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)
CAP(controlled attenuation parameter)
Assess the changes of controlled attenuation parameter based on ultrasound after oral administration of BGT-002
Time frame: Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)y29、Day56
LSM(Liver Stiffness Measuremen)
Assess the changes of liver stiffness measurement after oral administration of BGT-002
Time frame: Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)
BMI(Body Mass Index)
Changes of Body Mass Index were assessed after oral administration of BGT-002
Time frame: Day1, Day29/early withdrawal, and Day56 (± 5 days)
ALT(Alanine Aminotransferase)
Changes of Alanine Aminotransferase were assessed after oral administration of BGT-002
Time frame: Day1, Day29/early withdrawal, and Day56 (± 5 days)
ASTc(Aspartate Transaminase)
Changes of Aspartate Transaminase were assessed after oral administration of BGT-002
Time frame: Day1, Day29/early withdrawal, and Day56 (± 5 days)
TG(Triglyceride)
Changes of Triglyceride were assessed after oral administration of BGT-002
Time frame: Day1, Day29/early withdrawal, and Day56 (± 5 days)
LDL-C(Low-Density Lipoprotein Cholesterol)
Changes of Low-Density Lipoprotein Cholesterol were assessed after oral administration of BGT-002
Time frame: Day1, Day29/early withdrawal, and Day56 (± 5 days)
TC(total cholesterol)
Changes of serum total cholesterol were assessed after oral administration of BGT-002
Time frame: Day1, Day29/early withdrawal, and Day56 (± 5 days)