A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B

Last updated: March 3, 2025
Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

Placebo to match GST-HG131

GST-HG131

Clinical Study ID

NCT06263959
GST-HG131-II-01
  • Ages 35-65
  • All Genders

Study Summary

A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to sign the informed consent form,and fully understand the test content,process and possible adverse reactions;

  2. Males and females aged 35-65 ,able to complete research in accordance with test planrequirements;

  3. Participants who have no childbearing plan in next year,and must agree tovoluntarily use the contraceptive methods specified in the protocol from screeningto 6 months after the last dose of the study;

  4. The weight of male patients shall not be less than 50 kg, and the weight of femalepatients is not less than 45 kg. Body mass index (BMI = weight (kg)/height 2 (m2))in the range of 18.0~35.0 kg/m2;

  5. Participants who have received stable NA therapy for more than half a year and havemaintained the NA regimen for ≥3 months prior to screening;

  6. At least two tests within 28 days of the screening period (more than 1 week apart)with HBV DNA lower than LLOQ;

  7. HBeAg negative, 100≤HBsAg quantitative ≤1500 IU/mL, serum ALT<1×ULN duringscreening;

  8. The normal or abnormal results of vital signs assessment, physical examination and 12-lead electrocardiogram during the screening period and baseline period have noclinical significance;

  9. Able to communicate well with clinical staff and complete the trial according toprotocol requirements。

Exclusion

Exclusion Criteria:

  1. Participants with a history of allergy to the any ingredient or excipients of thedrug under study;

  2. Patients who cannot tolerate venous blood collection and have a history of needlefainting or blood fainting;

  3. Patients with major trauma or major surgery within 3 months before screening; orplan to have surgery during the study;

  4. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or receivedblood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior toscreening;

  5. A history of alcohol or drug abuse or dependence;

  6. Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration;

  7. Use of any hepatitis B drug other than NUC within 1 year prior to administration;

  8. Participants with systemic use of immunosuppressants, immunomodulators (excludinginterferon) and cytotoxic drugs within 6 months before screening; Or those whoreceived live attenuated vaccine within 1 month before screening;

  9. Participants with clinically significant acute or chronic liver disease caused bynon-HBV infection who were judged by the investigator to be unsuitable for thestudy;

  10. Participants with a history of cirrhosis (e.g., the subject had a histopathologicalexamination of the liver and reported cirrhosis, or had an endoscopic examinationindicating varicose esophagus and fundus veins);

  11. Participants with hepatitis B cirrhosis in the confirmed or suspected decompensatedstage, including but not limited to: hepatic encephalopathy, hepatorenal syndrome,esophageal and fundus variceal bleeding, spleen enlargement, ascites, primary livercancer, etc;

  12. Participants with malignancy or history of other malignancies within 5 years priorto screening (except cured basal cell or squamous cell carcinoma of the skin andcarcinoma in situ of the cervix);

  13. The investigators determined the presence of impaired gastrointestinal function orgastrointestinal disease that might affect oral drug absorption, such as severegastrointestinal disease (peptic ulcer, erosive or atrophic gastritis), partialgastrectomy, and gastrointestinal symptoms > grade 2 at the time of screening (e.g.,nausea, vomiting, or diarrhea);

  14. Participants with suspected or confirmed acute infections within 2 weeks prior torandomization;

  15. Laboratory examination: platelet count < 90 x 10^9 / L; White blood cell count <3.0x 10^9 / L; Neutrophils absolute value< 1.3 x 10^9 / L; Serum total bilirubin >2 xULN. Albumin< 30 g/L; Creatinine clearance ≤ 60 mL/min or less; Prothrombin timeinternational standardization ratio (INR) >1.5;

  16. Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) or imaging suggest possiblemalignant liver placeholder;

  17. Hepatitis C antibody positive, treponema pallidum antibody positive and rapid plasmareagin test (RPR) positive,AIDS antigen/antibody positive;

  18. Breastfeeding women or those who have a positive pregnancy test at screening orbaseline;

  19. The investigator believes that there are other subjects who are not suitable forparticipating in this trial.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Placebo to match GST-HG131
Phase: 2
Study Start date:
December 26, 2023
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing,
    China

    Active - Recruiting

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