A Phase 1 interventional study of GST-HG141 tablets and Placebo in Hepatitis B, sponsored by Fujian Cosunter Pharmaceutical Co. Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Fujian Cosunter Pharmaceutical Co. Ltd · Phase 1, Interventional, and Treatment
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 104 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Fujian Cosunter Pharmaceutical Co. Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: GST-HG141 tablets
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.
Drug: Placebo
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.
Drug: GST-HG141 tablets
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.
Drug: Placebo
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.
Drug: GST-HG141 tablets
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.
Drug: GST-HG141 tablets
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.
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.
Area Under Curve (AUC)
Plasma samples were collected at different points for pharmacokinetic analysis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Ae(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis
Time frame: 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.
Fe(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis
Time frame: 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.
Plan to share: No
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Fujian Cosunter Pharmaceutical Co. Ltd