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

Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760781
Collaborator
Beijing Sanuo Jiayi Biotechnology Co. LTD (Other)
32
Enrollment
4
Locations
4
Arms
72
Anticipated Duration (Months)
8
Patients Per Site
0.1
Patients Per Site Per Month

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: STSG-0002 Injection
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2029

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

  1. Number of subjects of adverse events [Baseline to Day 180]

  2. Number of subjects With Significant Abnormal Physical Examination [Baseline to Day 180]

  3. Number of subjects of Significant Abnormal Vital Signs Findings [Baseline to Day 180]

  4. Number of Participants With Significant Abnormal Laboratory Values [Baseline to Day 180]

  5. Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings [Baseline to Day 180]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

    1. 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.
Responsible Party:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT05760781
Other Study ID Numbers:
  • STS-STSG0002-002
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic

Study Results

No Results Posted as of Mar 8, 2023