Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Study Details
Study Description
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(Long-term follow-up).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: lowest dose treatment group Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements |
Drug: STSG-0002 Injection
Intravenous infusion
|
Experimental: low dose treatment group Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements |
Drug: STSG-0002 Injection
Intravenous infusion
|
Experimental: Intermediate dose treatment group Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements |
Drug: STSG-0002 Injection
Intravenous infusion
|
Experimental: A single high dose of treatment group Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements |
Drug: STSG-0002 Injection
Intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- Number of subjects of adverse events [Baseline to Day 180]
- Number of subjects With Significant Abnormal Physical Examination [Baseline to Day 180]
- 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 Electrocardiography (ECG) Findings [Baseline to Day 180]
Eligibility Criteria
Criteria
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;
-
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Peking University First Hospital | Beijing | Beijing | China | 100032 |
2 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
3 | Beijing Youan Hospital,Capital Medical | Beijing | Beijing | China | 100069 |
4 | The Second Affiliated Hospital of Chongqing Medical | Chongqing | Chongqing | China | 401437 |
Sponsors and Collaborators
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Beijing Sanuo Jiayi Biotechnology Co. LTD
Investigators
- Principal Investigator: Guiqiang Wang, Peking University First Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STS-STSG0002-002-LTFU