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
Overview
- Phase
- Phase 2
- Intervention
- GST-HG131
- Conditions
- Chronic Hepatitis B
- Sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change from Baseline in HBsAg levels
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to sign the informed consent form，and fully understand the test content, process and possible adverse reactions；
- •Males and females aged 35-65 ,able to complete research in accordance with test plan requirements;
- •Participants who have no childbearing plan in next 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；
- •The weight of male patients shall not be less than 50 kg, and the weight of female patients 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；
- •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；
- •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 quantitative ≤1500 IU/mL, serum ALT\<1×ULN during screening;
- •The normal or abnormal results of vital signs assessment, physical examination and 12-lead electrocardiogram during the screening period and baseline period have no clinical significance；
- •Able to communicate well with clinical staff and complete the trial according to protocol requirements。
Exclusion Criteria
- •Participants with a history of allergy to the any ingredient or excipients of the drug under study；
- •Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting；
- •Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study；
- •Blood donation or blood loss ≥400 mL within 3 months prior to screening, or received blood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior to screening；
- •A history of alcohol or drug abuse or dependence；
- •Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration；
- •Use of any hepatitis B drug other than NUC within 1 year prior to administration；
- •Participants with systemic use of immunosuppressants, immunomodulators (excluding interferon) and cytotoxic drugs within 6 months before screening; Or those who received live attenuated vaccine within 1 month before screening；
- •Participants with clinically significant acute or chronic liver disease caused by non-HBV infection who were judged by the investigator to be unsuitable for the study；
- •Participants with a history of cirrhosis (e.g., the subject had a histopathological examination of the liver and reported cirrhosis, or had an endoscopic examination indicating varicose esophagus and fundus veins);
Arms & Interventions
Cohort 1
Patiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 1) or placebo for 28 days.
Intervention: GST-HG131
Cohort 1
Patiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 1) or placebo for 28 days.
Intervention: Placebo to match GST-HG131
Cohort 2
Patiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 2) or placebo for 28 days.
Intervention: GST-HG131
Cohort 2
Patiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 2) or placebo for 28 days.
Intervention: Placebo to match GST-HG131
Cohort 3
Patiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 1 or 2) or placebo for 12 weeks.
Intervention: GST-HG131
Cohort 3
Patiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 1 or 2) or placebo for 12 weeks.
Intervention: Placebo to match GST-HG131
Outcomes
Primary Outcomes
Change from Baseline in HBsAg levels
Time Frame: Baseline and up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3)
Change from Baseline in HBsAg levels
Secondary Outcomes
- Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs(Up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3))