Status:
TERMINATED
A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002
Lead Sponsor:
Yisheng Biopharma (Singapore) Pte. Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatmen...
Detailed Description
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatmen...
Eligibility Criteria
Inclusion
- Age ≥ 18 years during screening
- Body Mass Index (BMI) of 18.5-30 kg/m2
- Diagnosed or laboratory confirmed to have CHB
- Have CHB infection for at least 6 months
- HBsAg titer ≥ 1000 IU/mL
- HBV DNA ≥ 2000 IU/mL
- Serum alanine amino transferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN)
- Able to provide informed consent
- Able and willing to comply with all study procedures throughout the study period of approximately 3 months
- For female subjects with childbearing potential: must agree to avoid pregnancy throughout the study period of approximately 3 months. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods on avoiding pregnancy include: a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with a spermicide.
Exclusion
- Pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial
- Transient elastography at screening revealing a FibroScan value of ≥ 9 kPa or a previous liver biopsy evidencing hepatic fibrosis at or within 24 months prior to vaccination
- Patients with hepatitis caused by other etiologies
- History of or manifestations of liver decompensation (e.g., Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, etc....)
- Currently participating in or has participated in a study with an IP within 30 days preceding Day 0
- Fever (axillary temperature ≥ 37.8 ℃)
- Subjects with abnormal indicators of blood biochemistry and other routine blood tests deemed clinically significant by the investigator
- History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema, or allergic abdominal pain) or allergy to any of the components of YS-HBV-002
- Any history of anaphylaxis or angioedema after any vaccination
- Allergy to kanamycin and aminoglycosides
- Past or family history of convulsion, epilepsy, encephalopathy, or mental illness
- Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases
- History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease)
- Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on the investigator's judgement
- Vaccinated with live attenuated vaccine within 1 month, or other vaccine/non-COVID-19 vaccine within 14 days prior to vaccination
- Receiving immunotherapy or inhibitor therapy (consistently oral or infusion for more than 14 days) within 3 months prior to vaccination
- Received systemic immunosuppressants within 4 months prior to vaccination or anticipating the need for immunosuppressant at any time during participation in the study. Topical or inhaled treatment is allowed if not used within 14 days prior to vaccination
- Have received antiviral therapy for chronic hepatitis but have stopped for less than 30 days or plan to take antiviral therapy during the study
- Received blood products within 3 months before vaccine administration
- History of alcohol or drug abuse within the past 2 years
- Any condition that, in the opinion of the investigator, would pose a health risk to the patient if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06162299
Start Date
July 1 2024
End Date
October 31 2024
Last Update
February 24 2025
Active Locations (1)
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1
Iloilo Doctors' Hospital
Iloilo City, Philippines