Hepatitis BPhase 1NCT04499443
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets
A Phase 1 study testing GST-HG131 tablets in people with Hepatitis B, run by Fujian Cosunter Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- GST-HG131 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2020to 31 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
- Ability to complete research in accordance with test plan requirements;
- Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
- Male and female healthy subjects aged 18 to 55 years (including 18 and 55 years old);
- Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 ~ 28 kg / m2 (including critical value);
- Physical examination, normal or abnormal vital signs have no clinical significance.
Who cannot join
- Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
- Allergies (multiple drugs and food allergies);
- Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Blood donation or massive blood loss (> 450 mL) within three months before screening;
- Take any drug that changes the activity of liver enzymes 28 days before screening;
- Took any prescription drugs, over-the-counter drugs, any vitamin products, or herbs within 14 days before screening;
Show all 22Show fewer
- Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening;
- Combined with inhibitors or inducers of CYP3A4, such as itraconazole, ketoconazole, etc.;
- Major changes in diet or exercise habits recently;
- Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
- Have a history of dysphagia or any gastrointestinal disease that affects drug absorption;
- Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
- Subjects who cannot tolerate a standard meal (two boiled eggs, a piece of buttered bacon toast, a box of fried potato strips, a cup of full-fat milk) (this strip is only applicable to subjects participating in post-meal trials);
- Abnormal ECG has clinical significance;
- Female subjects were breastfeeding during the screening period or during the trial or were preparing for pregnancy recently or had a positive serum pregnancy result;
- Clinical laboratory examinations are abnormal and clinically significant, or the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease);
- Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;
- Acute disease or concomitant medication occurs from the screening stage to before study medication;
- Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
- Have taken any alcohol-containing product within 24 hours before taking the study drug;
- People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
- The investigator believes that there are other subjects who are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130000
Junqi Niu, PHD
About this study
Official title: To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects
To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects
Read the detailed description
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100mg, 150 mg, 200 mg, 250 mg and 300 mg. Based on the results of a single dose, select 1 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-HG131 pharmacokinetics.
- Conditions
- Hepatitis B
- Being tested
- GST-HG131 tablets, Placebo
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG131 tabletsDrug
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.
PlaceboDrug
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.
| Study group | Role | What they receive |
|---|---|---|
| Single-dose experimental group | Experimental | 10mg, 30mg, 60mg, 100mg, 150mg, 200mg, 250mg and 300mg 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，Day4 and Day6. 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. Receives: Drug: GST-HG131 tablets |
| Single-dose control group | Placebo comparator | 10mg, 30mg, 60mg, 100mg, 150mg, 200mg, 250mg and 300mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo. Receives: Drug: Placebo |
| 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. 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, Day8 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. Receives: Drug: GST-HG131 tablets |
| Multi-dose control group | Placebo comparator | According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo. Receives: Drug: Placebo |
| 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 Day2, Day4 and Day6 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. Receives: Drug: GST-HG131 tablets |
| 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 Day2, Day4 and Day6 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. Receives: Drug: GST-HG131 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: 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.
Area Under Curve (AUC)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: 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: 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: 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.
Secondary outcomes (2)
Ae(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start18 Aug 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cosunter Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, PHD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499443
- Sponsor's protocol ID
- GST-HG131-20-02
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu Y, Sun F, Yuan Q, Du J, Hu L, Gu Z, Zhou Q, Du X, He S, Sun Y, Wang Q, Fan L, Wang L, Qin S, Chen S, Li J, Wu W, Mao J, Zhou Y, Zhou Q, Zhang G, Ding CZ. Discovery and preclinical evaluations of GST-HG131, a novel HBV antigen inhibitor for the treatment of chronic hepatitis B infection. Bioorg Med Chem Lett. 2022 Nov 1;75:128977. doi: 10.1016/j.bmcl.2022.128977. Epub 2022 Sep 8.
PubMed 36089112Li X, Liu Y, Yao H, Wang M, Gao L, Lou J, Mao J, Wu W, Zhou Y, Tang Y, Yan W, Hu Y, Ding C, Chen S, Niu J, Ding Y. Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Expression Inhibitor GST-HG131 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial. Antimicrob Agents Chemother. 2022 May 17;66(5):e0009422. doi: 10.1128/aac.00094-22. Epub 2022 Apr 11.
PubMed 35404074
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04499443
- Acronym / sponsor ID
- GST-HG131-20-02
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Fujian Cosunter Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects
Detailed description
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100mg, 150 mg, 200 mg, 250 mg and 300 mg. Based on the results of a single dose, select 1 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-HG131 pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single-dose experimental group | Experimental | Drug: GST-HG131 tablets10mg, 30mg, 60mg, 100mg, 150mg, 200mg, 250mg and 300mg 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，Day4 and Day6. 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. |
| Single-dose control group | Placebo comparator | Drug: Placebo10mg, 30mg, 60mg, 100mg, 150mg, 200mg, 250mg and 300mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo. |
| Multi-dose experimental group | Experimental | Drug: GST-HG131 tabletsAccording to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups. 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, Day8 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. |
| Multi-dose control group | Placebo comparator | Drug: PlaceboAccording to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo. |
| Food Impact Study Group A | Experimental | Drug: GST-HG131 tabletsGroup 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 Day2, Day4 and Day6 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. |
| Food Impact Study Group B | Experimental | Drug: GST-HG131 tabletsGroup 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 Day2, Day4 and Day6 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
- Ability to complete research in accordance with test plan requirements;
- Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
- Male and female healthy subjects aged 18 to 55 years (including 18 and 55 years old);
- Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 ~ 28 kg / m2 (including critical value);
Key exclusion criteria (22 listed)
- Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
- Allergies (multiple drugs and food allergies);
- Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Blood donation or massive blood loss (> 450 mL) within three months before screening;
- Take any drug that changes the activity of liver enzymes 28 days before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GST-HG131 tabletsThis trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies. | Drug | Food Impact Study Group A, Food Impact Study Group B, Multi-dose experimental group, Single-dose experimental group |
| PlaceboThis trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies. | Drug | Multi-dose control group, Single-dose control group |
Primary outcome
Peak Plasma Concentration (Cmax)
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.
Plasma samples were collected at different points for pharmacokinetic analysis
Area Under Curve (AUC)
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.
Plasma samples were collected at different points for pharmacokinetic analysis
T1/2
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.
Plasma samples were collected at different points for pharmacokinetic analysis
Cl/F
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.
Plasma samples were collected at different points for pharmacokinetic analysis
2 secondary outcomes
Ae(0~120h)
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)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Derived from this study: PubMed 36089112Hu Y, Sun F, Yuan Q, Du J, Hu L, Gu Z, Zhou Q, Du X, He S, Sun Y, Wang Q, Fan L, Wang L, Qin S, Chen S, Li J, Wu W, Mao J, Zhou Y, Zhou Q, Zhang G, Ding CZ. Discovery and preclinical evaluations of GST-HG131, a novel HBV antigen inhibitor for the treatment of chronic hepatitis B infection. Bioorg Med Chem Lett. 2022 Nov 1;75:128977. doi: 10.1016/j.bmcl.2022.128977. Epub 2022 Sep 8.
- Derived from this study: PubMed 35404074Li X, Liu Y, Yao H, Wang M, Gao L, Lou J, Mao J, Wu W, Zhou Y, Tang Y, Yan W, Hu Y, Ding C, Chen S, Niu J, Ding Y. Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Expression Inhibitor GST-HG131 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial. Antimicrob Agents Chemother. 2022 May 17;66(5):e0009422. doi: 10.1128/aac.00094-22. Epub 2022 Apr 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junqi Niu, PHD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GST-HG131 tablets in people with Hepatitis B, run by Fujian Cosunter Pharmaceutical Co. Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanan Tang, MD (+86 13585734994, annie_tyn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04499443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.