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To Evaluate the Tolerability and Pharmacokinetics of GST-HG141 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies. To evaluate the tolerance of GST-HG141 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG141 pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose experimental group | Experimental | 50mg, 100mg, 200mg, 300mg, 400mg, 500mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo. Each group was administered once, under the fasting condition of Day1, and the tolerance was evaluated on Day2 and Day4. Subjects in different dose groups were enrolled in turn, and the next set of trials was conducted on the premise that the previous set of tolerability assessments were tolerated. The actual completion of the final dose, depending on the test results. |
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| Single-dose control group | Placebo Comparator | 50mg, 100mg, 200mg, 300mg, 400mg, 500mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo. |
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| Multi-dose experimental group | Experimental | According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups at 100 mg, 200 mg, 300 mg, and 400 mg. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo. It is necessary to decide the multiple administration method and dosage according to the result of single administration, which is initially determined to be once a day. After the first dose, Day3, Day6, and Day12 were evaluated for tolerance, and the next group of tests was conducted under the premise that the previous group of Day12 tolerance evaluation was tolerated. |
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| Multi-dose control group | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG141 tablets | Drug | This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol. |
| Peak Plasma Concentration (Cmax) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol. |
| T1/2 | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol. |
| Cl/F | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Ae(0~120h) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanan Tang, MD | Contact | +86 13585734994 | annie_tyn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junqi Niu, PHD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups at 100 mg, 200 mg, 300 mg, and 400 mg. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo. |
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| Food Impact Study Group A | Experimental | 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. 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. In group A, the tolerance evaluation was conducted on Day 2 and Day 4 after the first administration. After the first dose of group A is completed and the tolerability evaluation result is considered tolerable, the second cycle of this group and the first cycle of group B can be carried out. |
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| Food Impact Study Group B | Experimental | 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. 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. In group A, the tolerance evaluation was conducted on Day 2 and Day 4 after the first administration. After the first dose of group A is completed and the tolerability evaluation result is considered tolerable, the second cycle of this group and the first cycle of group B can be carried out. |
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| Placebo | Drug | This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies. |
|
| Fe(0~120h) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |