To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B

Study Overview
=================
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.

Official Title
-----------------
Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy

Conditions
-----------------
Chronic Hepatitis b

Intervention / Treatment
-----------------
* Drug: STSG-0002 Injection


Participation Criteria
=================
Eligibility 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; 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lowest dose treatment group<br>Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements | Drug: STSG-0002 Injection<br>* Intravenous infusion<br>|
| Experimental: low dose treatment group<br>Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements | Drug: STSG-0002 Injection<br>* Intravenous infusion<br>|
| Experimental: Intermediate dose treatment group<br>Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements | Drug: STSG-0002 Injection<br>* Intravenous infusion<br>|
| Experimental: A single high dose of treatment group<br>Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements | Drug: STSG-0002 Injection<br>* Intravenous infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |