Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGT-002 | Drug | taking the study drug orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | From Day 1 to Day 56 | |
| C-QTc(Concentration-QTc) | To investigate the effect of BGT-002 on QT/QTc interval in subjects | Day1、Day28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(Peak Concentration) | The peak concentration of BGT-002 tablets was assessed after oral administration of BGT-002 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ding Yanhua, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2023 | May 30, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2024 | May 30, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
taking the placebo orally |
|
| Day1 |
| AUC(0-24h)(Area Under Curve) | The area under the curve was assessed 0 to 24 hours after oral administration of BGT-002 | Day1 |
| Cmax,ss | The peak concentration at stable state was assessed after oral administration of BGT-002 | Day28 |
| Tmax,ss | The peak time at stable state was assessed after oral administration of BGT-002 | Day28 |
| AUCss | The area under the curve at stable state after the subject's oral administration of BGT-002 was assessed | Day28 |
| CLss/F(Steady-State Clearance/bioavailability,F) | The clearance rate at stalbe state was assessed after oral administration of BGT-002 | Day28 |
| Cmin,ss | Assess valley concentrations at stable state after oral administration of BGT-002 | Day28 |
| Rac(Accumulation Ratio) | Assess the drug accumulation index after oral administration of BGT-002 | 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 | 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 | 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 | 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 | Day1, Day29/early withdrawal, and Day56 (± 5 days) |
| ALT(Alanine Aminotransferase) | Changes of Alanine Aminotransferase were assessed after oral administration of BGT-002 | Day1, Day29/early withdrawal, and Day56 (± 5 days) |
| ASTc(Aspartate Transaminase) | Changes of Aspartate Transaminase were assessed after oral administration of BGT-002 | Day1, Day29/early withdrawal, and Day56 (± 5 days) |
| TG(Triglyceride) | Changes of Triglyceride were assessed after oral administration of BGT-002 | 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 | Day1, Day29/early withdrawal, and Day56 (± 5 days) |
| TC(total cholesterol) | Changes of serum total cholesterol were assessed after oral administration of BGT-002 | Day1, Day29/early withdrawal, and Day56 (± 5 days) |