Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B

Inclusion Criteria

• Male and female subjects aged 18-65 years.
• Diagnosed with chronic hepatitis B defined as HBsAg positive for at least 24 months.
• Subject has received entecavir or tenofovir for at least 2 years with a stable dose for at least 6 months prior to screening.
• HBeAg negative for at least 2 years prior to inclusion in the study.
• HBV DNA 11.5 KPa), or previous history or evidence of cirrhosis on radiological imaging, Fibroscan or liver biopsy.
• Positive serology for HIV-1 or HIV-2 or HCV or HDV antibodies.
• Immunodeficient or autoimmune conditions due to disease or medication e.g. systemic steroids within previous 12 weeks. (Topical or inhaled steroids are permissible).
• Clinically relevant co-morbidity, e.g. autoimmune disease.
• Clinically relevant anaemia or leukopenia in the opinion of the investigator.
• Cancer or treatment for cancer within 3 years prior to screening excluding basal cell carcinoma of the skin, which is allowed.
• Known or suspected intolerance or hypersensitivity to the IMP or closely related compounds or any of the stated ingredients.
• Receipt of any IMP within 90 days prior to screening or currently receiving IMP or intent to receive IMP.
• Current substance or alcohol abuse that in the opinion of the Investigator would interfere with compliance or with interpretation of study results.
• Any condition that in the opinion of the Investigator might interfere with study objectives.
• Pregnant or breastfeeding.
• Subjects should not have received, during the 6 month period prior to screening, any medications or other treatments that may adversely affect the immune system such as allergy injections, immunoglobulins, interferons, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable).

Immunosuppressive treatment such as azathioprine or mercaptopurine is not permitted 6 months prior to screening.

• Administration of live vaccines (such as live influenza vaccinations or live travel vaccinations) from 10 days prior to the screening visit until Day 85.