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

Inclusion Criteria:

1. Volunteer to participate in the study, be able to understand the requirements of aclinical study, and sign informed consent form.
2. Aged ≥ 18 and ≤ 55 years older, male and female.
3. Body weight ≥ 50 kg for male, body weight ≥ 45 kg for female, and body mass index (BMI) scores between ≥ 18 kg/m2 and ≤ 32.0 kg/m2.
4. Vital signs, physical examination, laboratory tests and 12-lead ECG, etc. withinnormal limits; or, with no clinically significant abnormalities as determined by theinvestigator.
5. A male participant must agree to use adequate contraception from screening through atleast 12 weeks after the last dose of investigational product or placebo. Refer toSection 5.5 for more information on highly effective methods of contraception.
6. Women of childbearing potential must have a negative pregnancy test prior to thedosing administration, and agree to use adequate contraception from screening throughat least 12 weeks after the last dose of investigational product or placebo. A femaleparticipant of non-childbearing potential will have had at least 12 continuous monthsof natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level > 40mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate,history of vasomotor symptoms); or have had surgical bilateral oophorectomy,hysterectomy or tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5for more information on highly effective methods of contraception

Exclusion Criteria:

1. History of anaphylaxis or clinically significant drug allergy or drug allergywitnessed in previous studies with experimental drugs, or allergy to the activeingredients 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 notlimited to a history of alcoholic liver disease, non-alcoholic steatohepatitis, drugor autoimmune liver disease.
4. History or presence of immune-mediated diseases, including but not limited toidiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoidarthritis.
5. History or presence of any chronic infectious condition, including but not limited totuberculosis 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 × ULNor total bilirubin > 1.2 × ULN.
10. Any other concomitant disease, condition or treatment that could interfere with theconduct 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 theinterpretation of study data.
11. Took any prescription drugs or over-the-counter drugs within 2 weeks prior toinvestigational product or placebo administration, or took any drugs within 5half-lives at the time of investigational product or placebo administration (whicheveris longer), but vitamins, supplements and topical corticosteroids will be permittedwithin 2 weeks prior to investigational product or placebo administration; or, tookany herbal medicines within 30 days before investigational product or placeboadministration.
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 beforescreening, or any covid-19 vaccine within 2 weeks before screening.
13. Those who donated plasma within 7 days prior to the dosing administration or donatedor lost blood 500 mL or more within 8 weeks prior to the dosing administration, orplan 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 undergosurgery during the study.
15. Those who are participating in other clinical studies, or currently not participatingin 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 forother causes.