Hepatitis BPhase 1NCT04868981
Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets
A Phase 1 study testing GST-HG141 tablets in people with Hepatitis B, run by Fujian Cosunter Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B (CHB) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- GST-HG141 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 14 Mar 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent before the study and fully understand the content and process of the study as well as the possible adverse drug reactions;
- Be able to complete the study in accordance with protocol requirements;
- Subjects (including partners) are willing to take effective contraceptive measures from completion of screening to 6 months after the last Administration;
- Ages ranged from 18 to 70 years old (including 18 and 70 years old);
- Male subjects weighing no less than 45 kg, and female subjects weighing no less than 40 kg. [Body mass index (BMI) = body weight (kg) / height 2 (m^2)], body mass index is in the range of 18 ~ 32 kg / m^2 (including critical value);
- Patients with HBsAg-positive for at least 6 months (based on outpatient/inpatient medical records or laboratory report; or with IgM HBcAb-negative and HBsAg-positive when screening;
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- Patients without interferon/nucleoside analogue treatment when screening, or interferon treatment was stopped more than 1 year ago, and nucleoside analogue treatment was stopped more than 6 months ago.
- For HBeAg-positive patients, HBV DNA ≥ 2×10^5 IU/mL; For HBeAg-negative patients, HBV DNA ≥ 2×10^4 IU/mL;
- Patients with Serum ALT less than 5×ULN when screening.
Who cannot join
- Patients with suspected allergy to any component of the study drug or allergic constitution (multiple drug and food allergy)；
- Patients who had major trauma or Large surgical operation within 3 months before screening or are planning to take surgical treatment during the study ;
- Patients who had blood donation or massive blood loss (≥400 mL), or had a blood transfusion within 3 months before screening; or had blood donation or massive blood loss (≥200 mL) within 1 months before screening;
- Patients with smoking more than 5 cigarettes per day within 3 months before the study or heavy drinking within 4 weeks before screening (drinking more than 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine)；
- Patients who had used immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before dosing, or had received live attenuated vaccine within 1 month before screening;
- Patients who used immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before dosing, or who had received live attenuated vaccine within 1 month before screening;
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- Patients with clinically significant acute or chronic liver disease caused by non HBV infection (fatty liver disease is ruled out or recruited by researcher);
- Patients with history of liver cirrhosis or progressive liver fibrosis (e.g., liver histopathology reported liver cirrhosis or endoscopy indicated esophageal and gastric varices);
- Patients with confirmed or suspected decompensated hepatitis B cirrhosis including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophageal and gastric variceal bleeding, splenomegaly, ascites, primary liver cancer, etc. ;
- Patients with history of other malignancies or complicating with other malignant tumors;
- Patients complicating with severe circulatory, digestive, respiratory, urinary, blood, metabolism, immune, nervous and other systemic;
- Patients with acute infection within 2 weeks before screening;
- Patients who had participated in clinical trials of drugs or medical devices within 1 month before screening;
- Patients who could not ban smoking, drinking, caffeinated food or drinks within 2 days before administration and during the study , and patients who have special dietary requirements and can not follow the unified diet;
- Laboratory examination: platelet count<90×10^9/L; leukocyte count<3.0×10^9/L; neutrophil absolute value<1.3×10^9/L; serum total bilirubin>2×ULN; albumin<30 g/L; creatinine clearance rate≤60ml/min (calculated by MDRD formula); international standardization ratio value of prothrombin time (INR) >1.5;
- Patients with Alpha fetoprotein (AFP) more than 50 UG / L or imaging findings of malignant liver lesions;
- Patients with HCAb-positive , AIDS Ag/Ab-positive, or positive syphilis spirochemical Ab simultaneously RPR test-positive;
- For patients with normal ALT or less than 2×ULN, LSM≥12.4 kPa; or for patients with ALT≥2×ULN, LSM≥17.0 kPa;
- Patients with positive urine drug screening (morphine, marijuana) or alcohol breath test;
- Patients with positive urine drug screening (morphine, marijuana) or alcohol breath test；
- Patients with other factors that are not suitable to participate in this study in researcher's thought.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B
To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B (CHB)
Read the detailed description
This study includes 3 cohorts of 25 mg BID, 50 mg BID and 100 mg BID. 30 patients with chronic hepatitis B will be enrolled in this study and each cohort will enroll 10 patients (GST-HG141 tablets : PBO=8:2). All enrolled patients will be given research drugs twice a day for 28 days (D28 was administered only once in the morning). And each cohort requires at least 4 subjects with elevated ALT. Tolerability, pharmacodynamics and pharmacokinetics will be evaluated according to the protocol.
- Conditions
- Hepatitis B
- Being tested
- GST-HG141 tablets, Matching Placebos for GST-HG141 tablets
- 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-HG141 tabletsDrug
Administrate GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses
Matching Placebos for GST-HG141 tabletsDrug
Administrate the placebos for GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses
| Study group | Role | What they receive |
|---|---|---|
| GST-HG141 | Experimental | GST-HG141 tablets at varying dosages by mouth for 28 days Receives: Drug: GST-HG141 tablets |
| Matching Placebo for GST-HG141 | Placebo comparator | Placebos for GST-HG141 tablets at varying dosages by mouth for 28 days Receives: Drug: Matching Placebos for GST-HG141 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities.
Symptoms and physical examination, clinical laboratory examination, vital signs，12 lead ECG and adrenal ultrasounds were collected and assessed by CTCAE v5.0.
Measured: Up to 33 days
Cmax of GST-HG141
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
AUC of GST-HG141
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
t1/2 of GST-HG141
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
Cl/F of GST-HG141
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
Secondary outcomes (4)
The value of serum HBV DNA decreased from baseline
Plasma samples were collected at different points for pharmacodynamics analysis
Measured: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
The value of serum HBV pgRNA decreased from baseline
Plasma samples were collected at different points for pharmacodynamics analysis
Measured: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
The value of serum HBsAg decreased from baseline
Plasma samples were collected at different points for pharmacodynamics analysis
Measured: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
The value of serum HBeAg decreased from baseline
Plasma samples were collected at different points for pharmacodynamics analysis
Measured: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start31 May 2021
- Primary completion23 Feb 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 30 participants (actual)
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
- NCT04868981
- Sponsor's protocol ID
- GST-HG141-21-01
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu M, Mai J, Zhang H, Zhang G, Mao J, Tang Y, Yan W, Wu W, Hou J, Liang X, Liu Z, Ding Y, Niu J. Safety, pharmacokinetics, and antiviral efficacy of the novel capsid assembly modulator GST-HG141 in patients with chronic hepatitis B: a phase 1 trial with a randomized, placebo-controlled design. Virol J. 2024 Dec 20;21(1):328. doi: 10.1186/s12985-024-02584-8.
PubMed 39707469
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT04868981
- Acronym / sponsor ID
- GST-HG141-21-01
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fujian Cosunter Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 3 May 2021 (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 Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B (CHB)
Detailed description
This study includes 3 cohorts of 25 mg BID, 50 mg BID and 100 mg BID. 30 patients with chronic hepatitis B will be enrolled in this study and each cohort will enroll 10 patients (GST-HG141 tablets : PBO=8:2). All enrolled patients will be given research drugs twice a day for 28 days (D28 was administered only once in the morning). And each cohort requires at least 4 subjects with elevated ALT. Tolerability, pharmacodynamics and pharmacokinetics will be evaluated according to the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GST-HG141 | Experimental | Drug: GST-HG141 tabletsGST-HG141 tablets at varying dosages by mouth for 28 days |
| Matching Placebo for GST-HG141 | Placebo comparator | Drug: Matching Placebos for GST-HG141 tabletsPlacebos for GST-HG141 tablets at varying dosages by mouth for 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign the informed consent before the study and fully understand the content and process of the study as well as the possible adverse drug reactions;
- Be able to complete the study in accordance with protocol requirements;
- Subjects (including partners) are willing to take effective contraceptive measures from completion of screening to 6 months after the last Administration;
- Ages ranged from 18 to 70 years old (including 18 and 70 years old);
- Male subjects weighing no less than 45 kg, and female subjects weighing no less than 40 kg. [Body mass index (BMI) = body weight (kg) / height 2 (m^2)], body mass index is in the range of 18 ~ 32 kg / m^2 (including critical value);
Key exclusion criteria (21 listed)
- Patients with suspected allergy to any component of the study drug or allergic constitution (multiple drug and food allergy)；
- Patients who had major trauma or Large surgical operation within 3 months before screening or are planning to take surgical treatment during the study ;
- Patients who had blood donation or massive blood loss (≥400 mL), or had a blood transfusion within 3 months before screening; or had blood donation or massive blood loss (≥200 mL) within 1 months before screening;
- Patients with smoking more than 5 cigarettes per day within 3 months before the study or heavy drinking within 4 weeks before screening (drinking more than 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine)；
- Patients who had used immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before dosing, or had received live attenuated vaccine within 1 month 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-HG141 tabletsAdministrate GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses | Drug | GST-HG141 |
| Matching Placebos for GST-HG141 tabletsAdministrate the placebos for GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses | Drug | Matching Placebo for GST-HG141 |
Primary outcome
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities.
Time frame: Up to 33 days
Symptoms and physical examination, clinical laboratory examination, vital signs，12 lead ECG and adrenal ultrasounds were collected and assessed by CTCAE v5.0.
Cmax of GST-HG141
Time frame: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
Plasma samples were collected at different points for pharmacokinetic analysis
AUC of GST-HG141
Time frame: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
Plasma samples were collected at different points for pharmacokinetic analysis
t1/2 of GST-HG141
Time frame: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
Plasma samples were collected at different points for pharmacokinetic analysis
Cl/F of GST-HG141
Time frame: Measured on -0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12hours on Day1; -0.5 hours on Day 8, Day 15, Day22 and Day 27 for trough concentration; -0.5, 0.5 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours on Day 28.
Plasma samples were collected at different points for pharmacokinetic analysis
4 secondary outcomes
The value of serum HBV DNA decreased from baseline
Time frame: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
The value of serum HBV pgRNA decreased from baseline
Time frame: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
The value of serum HBsAg decreased from baseline
Time frame: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
The value of serum HBeAg decreased from baseline
Time frame: Plasma samples were collected before administation on the morning of day 1 and day 15 and at any time on day 29 and day 33
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 39707469Wu M, Mai J, Zhang H, Zhang G, Mao J, Tang Y, Yan W, Wu W, Hou J, Liang X, Liu Z, Ding Y, Niu J. Safety, pharmacokinetics, and antiviral efficacy of the novel capsid assembly modulator GST-HG141 in patients with chronic hepatitis B: a phase 1 trial with a randomized, placebo-controlled design. Virol J. 2024 Dec 20;21(1):328. doi: 10.1186/s12985-024-02584-8.
- 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-HG141 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 7 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities. (time frame: Up to 33 days). The study lists 5 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 NCT04868981, which also lists 1 linked publication.
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 7 Jun 2022.