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

Staidson Biopharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Chronic Hepatitis b

Treatments: Drug: STSG-0002 Injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05760781

STS-STSG0002-002

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 4 patient groups

lowest dose treatment group

Experimental group

Description:

Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements

Treatment:

Drug: STSG-0002 Injection

low dose treatment group

Experimental group

Description:

Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements

Treatment:

Drug: STSG-0002 Injection

Intermediate dose treatment group

Experimental group

Description:

Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements

Treatment:

Drug: STSG-0002 Injection

A single high dose of treatment group

Experimental group

Description:

Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements

Treatment:

Drug: STSG-0002 Injection