Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis B

NCT07709520 | Recruiting Phase 2

• 1 other identifier: GST-HG131&141-II-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBsAg decline from baseline at D168

  : Baseline and up to 168 days

Study Arms (3)

Experimental

EXPERIMENTAL

GST-HG141/GST-HG131

Drug: GST-HG141; Drug: GST-HG131

Placebo 1

PLACEBO COMPARATOR

GST-HG141 Placebo /GST-HG131

Drug: GST-HG131; Drug: GST-HG141 Placebo

Placebo 2

PLACEBO COMPARATOR

GST-HG141 Placebo/GST-HG131

Drug: GST-HG131; Drug: GST-HG141 Placebo

Interventions

GST-HG141 DRUG

GST-HG141 is a novel, potent and selective HBV CAM, which has a distinct molecular mechanism of its antiviral action compared to other CAMs reported in the literature, and has demonstrated strong antiviral properties in pre-clinical studies in vitro and in vivo.

Experimental

GST-HG141 Placebo DRUG

GST-HG141 Placebo

Placebo 1; Placebo 2

GST-HG131 DRUG

GST-HG131 is a novel dihydroquinolizinone (DHQ) compound, has been shown to reduce circulating levels of HBsAg in animals.

Experimental; Placebo 1; Placebo 2

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to sign the informed consent form and fully understand the test content, process and possible adverse reactions.
• Males and females aged 35-65 years(inclusive),able to complete research in accordance with test plan requirements.
• Participants who have no childbearing plan in a year,and must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 6 months after the last dose of the study.
• Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive).
• Participants who have received stable NA therapy for more than half a year， and have maintained the NA regimen for ≥3 months prior to Screening.
• HBV DNA concentration must be adequately suppressed, defined as At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ .
• HBeAg negative, 100≤HBsAg ≤1500 IU/mL, serum Alanine aminotransferase (ALT)\<1×upper limit of normal(ULN) during screening.
• Able to communicate well with clinical staff and complete the trial according to protocol requirements.

You may not qualify if:

• Participants with a history of allergy to any component of the investigational product, or allergic diathesis (allergies to multiple drugs and foods).
• Participants unable to tolerate venous blood collection, or with a history of needle syncope or blood phobia.
• Participants who sustained major trauma or underwent major surgery within 3 months prior to screening, or those planning to undergo surgery during the study period.
• Participants with a history of alcohol abuse (defined as alcohol intake \>14 standard units per week; one standard unit equals 350 mL beer, 120 mL wine, or 30 mL spirits with 40% alcohol by volume) or drug abuse/dependence at screening.
• Participants who participated in a clinical trial of any medicinal product or medical device (excluding in vitro diagnostic reagents) and received the investigational product or device within 3 months prior to study drug administration.
• Participants who received any anti-hepatitis B medications other than nucleos(t)ide analogues (NUCs), including marketed and unapproved agents, within 6 months prior to study drug administration.
• Participants who received immunosuppressants, immunomodulators (thymosin, interferons) or cytotoxic drugs within 6 months before study drug administration; or patients who received live attenuated vaccines or live vaccines within 1 month prior to screening.
• Participants with a medical history of liver cirrhosis or progressive liver fibrosis, defined as: liver histopathology confirming cirrhosis; endoscopy showing esophageal and gastric varices; or liver stiffness measurement (LSM) ≥9.0 kPa on transient elastography at screening.
• Participants with confirmed or suspected decompensated HBV-related cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, variceal bleeding of esophagus and stomach, splenomegaly, ascites, and primary liver cancer.
• Participants with concurrent malignant tumors or a history of other malignancies within 5 years prior to screening (excluding cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix); participants complicated with unstable cardiovascular and cerebrovascular diseases, uncontrolled diabetes (glycated hemoglobin \>7%), refractory hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, deemed ineligible by the investigator for study participation), or other relevant comorbidities.
• Participants judged by the investigator to have gastrointestinal impairment or disorders that may interfere with oral drug absorption, including severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, or gastrointestinal symptoms graded \>Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) at screening (e.g., nausea, vomiting, diarrhea).
• Participants with suspected or confirmed acute or chronic infection within 2 weeks prior to randomization.
• Abnormal laboratory parameters meeting any of the following thresholds:
• Platelet count \<100×10⁹/L; White blood cell count \<3.0×10⁹/L; Absolute neutrophil count \<1.3×10⁹/L; Serum total bilirubin \>2× upper limit of normal (ULN); Serum albumin \<35 g/L; Creatinine clearance ≤60 mL/min (calculated via the CKD-EPI equation); International normalized ratio (INR) of prothrombin time \>1.5.
• Participants with alpha-fetoprotein (AFP) \>50 µg/L or imaging suggestive of suspected malignant hepatic space-occupying lesions.

Sponsors & Collaborators

• Fujian Akeylink Biotechnology Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

GST-HG131

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

zhang tianxiang

CONTACT

13247651892; zhangtianxiang@akeylink.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (1)