To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Phase 2
Terminated
- Conditions
- Chronic Hepatitis b
- Interventions
- Drug: STSG-0002 Injection
- Registration Number
- NCT05760781
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Patients with chronic HBV；
- Receiving anti-HB viral therapy;
- 10 IU/ml≤HBsAg≤3000 IU/ml.
Exclusion Criteria
- Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;
- Liver cirrhosis;
- Hepatocellular carcinoma;
- Autoimmune liver disease;
- Clinical hepatic decompensation;
- Fibroscan>12 kPa;
- a. hemoglobin<110g/L（female）<120 g/L（male），platelet<ULN，white blood cell<2.5×109/L；b. bilirubin>1.5 ×ULN，ALT>2 × ULN，serum albumin<35 g/L；c. INR>1.5；d. serum creatinine >1.5×ULN.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description lowest dose treatment group STSG-0002 Injection Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements low dose treatment group STSG-0002 Injection Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements A single high dose of treatment group STSG-0002 Injection Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements Intermediate dose treatment group STSG-0002 Injection Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
- Primary Outcome Measures
Name Time Method Number of subjects of Significant Abnormal Vital Signs Findings Baseline to Day 180 Number of Participants With Significant Abnormal Laboratory Values Baseline to Day 180 Number of subjects With Significant Abnormal Physical Examination Baseline to Day 180 Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings Baseline to Day 180 Number of subjects of adverse events Baseline to Day 180
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
The Second Affiliated Hospital of Chongqing Medical
🇨🇳Chongqing, Chongqing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Youan Hospital,Capital Medical
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China