Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects

Exclusion Criteria

• •1. History of anaphylaxis or clinically significant drug allergy or drug allergy witnessed in previous studies with experimental drugs, or allergy to the active ingredients or excipients of the investigational product.
• •2. History of allergic reactions to monoclonal antibodies or antibody fragments.
• •3. History or presence of infectious or non-infectious liver disease, including but not limited to a history of alcoholic liver disease, non-alcoholic steatohepatitis, drug or autoimmune liver disease.
• •4. History or presence of immune-mediated diseases, including but not limited to idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis.
• •5. History or presence of any chronic infectious condition, including but not limited to tuberculosis or parasitic infections.
• •6. History of allogenic transplantation of organs, bone marrow or stem cell.
• •7. Active infection, or screening for infectious disease during the screening period (HBsAg, hepatitis C virus antibody \[HCV-Ab\], human immunodeficiency virus antibody \[HIV-Ab\], or syphilis antibody \[TP-Ab\]) is positive.
• •8. QTcF \>450 msec on 3 consecutive ECG recordings conducted at screening or baseline.
• •9. Alanine transaminase (ALT) \> 1.2 × ULN, aspartate aminotransferase (AST) \> 1.2 × ULN or total bilirubin \> 1.2 × ULN.
• •10. Any other concomitant disease, condition or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the subject in the study or interfere with the interpretation of study data.
• •11. Took any prescription drugs or over-the-counter drugs within 2 weeks prior to investigational product or placebo administration, or took any drugs within 5 half-lives at the time of investigational product or placebo administration (whichever is longer), but vitamins, supplements and topical corticosteroids will be permitted within 2 weeks prior to investigational product or placebo administration; or, took any herbal medicines within 30 days before investigational product or placebo administration.
• •12. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before screening, or any covid-19 vaccine within 2 weeks before screening.
• •13. Those who donated plasma within 7 days prior to the dosing administration or donated or lost blood 500 mL or more within 8 weeks prior to the dosing administration, or plan to donate during the study or within 8 weeks after the end of the study.
• •14. Those who underwent surgery within 4 weeks before screening, or plan to undergo surgery during the study.
• •15. Those who are participating in other clinical studies, or currently not participating in a study and have been dosed in another clinical study in the past 4 weeks.
• •16. Pregnant or lactating women.
• •17. Those who are determined disqualified to join clinical studies by investigator for other causes.