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

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(Long-term Follow-up)

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: STSG-0002 Injection

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Min Liu; Phone Number: +86 18519789088; Email: liumin@staidson.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
      • Contact: Bo Feng; Phone Number: +8613810254109; Email: fengbo@pkuph.edu.cn
    • Beijing, Beijing, China, 100032
      • Peking University first hospital
      • Contact: Guiqiang Wang; Phone Number: +8613911405123; Email: john131212@sina.com
    • Beijing, Beijing, China, 100069
      • Beijing Youan Hospital,Capital Medical
      • Contact: Sujun Zheng; Phone Number: +8615810716239; Email: zhengsujun003@126.com
  • Chongqing
    • Chongqing, Chongqing, China, 401437
      • The Second Affiliated Hospital of Chongqing Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Collaborators: Beijing Sanuo Jiayi Biotechnology Co. LTD
• Investigators: Principal Investigator: Guiqiang Wang, Peking University first hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: STS-STSG0002-002-LTFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No