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To Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Impact of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers
This trial includes single-dose studies,multiple-dose studies and food Impact studies, The single-dose study included eight doses groups of 5 mg, 15 mg, 30 mg, 60 mg, 90mg, 120 mg, 150 mg and 180 mg. Based on the results of a single dose, select 2 to 3 doses to conduct multiple dose studies. To evaluate the tolerance of GST-HG131 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG151 pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose experimental group | Active Comparator | 5mg,15mg,30mg,60mg,90mg,120mg,150mg and 180mg need to complete a single-dose clinical study. The first two dose groups had 4 subjects in each group (3 received GST-HG151 and 1 received placebo,randomly assigned), and the rest are 10 ubjects in each group (8 received GST-HG151 and 2 received placebo, randomly assigned) |
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| Single-dose control group | Placebo Comparator | 5mg,15mg,30mg,60mg,90mg,120mg,150mg and 180mg need to complete a single-dose clinical study. The first two dose groups had 4 subjects in each group (3 received GST-HG151 and 1 received placebo,randomly assigned), and the rest are 10 ubjects in each group (8 received GST-HG151 and 2 received placebo, randomly assigned) |
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| Multi-dose experimental group | Active Comparator | According to the results of the SAD, it is planned to carry out multiple-dose studies in 2 to 3 dose groups. Continuous administration, 12 subjects in each group(10 received GST-HG151 and 2 received placebo, randomly assigned) |
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| Multi-dose control group | Placebo Comparator | According to the results of the SAD, it is planned to carry out multiple-dose studies in 2 to 3 dose groups. Continuous administration, 12 subjects in each group(10 received GST-HG151 and 2 received placebo, randomly assigned) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG151 | Drug | Subjects will take GST-HG151 orally(once daily) on Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs | Safety assessments such as AEs and SAEs | SAD Cohorts : Up to Day 6. MAD Cohorts : Up to Day 14. Food Effect Cohorts : Up to Day 20. |
| Peak Plasma Concentration (Cmax) | Plasma samples were collected at different points for pharmacokinetic analysis | Before and at pre-specified time points up to 72 hours after dosing. |
| Area Under Curve (AUC) | Plasma samples were collected at different points for pharmacokinetic analysis | Before and at pre-specified time points up to 72 hours after dosing. |
| T1/2 | Plasma samples were collected at different points for pharmacokinetic analysis | Before and at pre-specified time points up to 72 hours after dosing. |
| Cl/F | Plasma samples were collected at different points for pharmacokinetic analysis | Before and at pre-specified time points up to 72 hours after dosing. |
| Ae | Plasma samples were collected at different points for pharmacokinetic analysis | Before and at pre-specified time points up to 72 hours after dosing. |
| Fe | Plasma samples were collected at different points for pharmacokinetic analysis | Before and at pre-specified time points up to 72 hours after dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanan Tang, Master | Contact | +86 13585734994 | annie_tyn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Zheng, Bachelor | Mengchao Hepatpbiliary Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengchao Hepatpbiliary Hospital of Fujian Medical University | Recruiting | Fujian | Fuzhou | 350025 | China |
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| Food Impact Study Group A | Active Comparator | According to the results of the SAD, it is planned to select 1 dose group,10 subjects(8 received GST-HG151 and 2 received placebo, randomly assigned),two cycles, crossover |
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| Food Impact Study Group B | Active Comparator | According to the results of the SAD, it is planned to select 1 dose group,8 subjects,two cycles, crossover |
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| Placebo |
| Drug |
Subjects will take Placebo orally(once daily) on Day 1 |
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| GST-HG151 | Drug | Subjects will take GST-HG151 orally (once daily) from Day 1 to Day 7 |
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| Placebo | Drug | Subjects will take Placebo orally (once daily) from day 1 to day 7 |
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| GST-HG151 | Drug | Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 ~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days. |
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| GST-HG151 | Drug | Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 ~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days. |
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