A Trial of HBM9378 in Healthy Chinese Subjects

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive HBM9378 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Inclusion criteria

• Written informed consent must be obtained.
• Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities.
• Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive).
• Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ;
• Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study.
• Can communicate successfully with the investigator and understand and comply with the requirements of this study.

Exclusion criteria

• History of relevant allergy/hypersensitivity.
• History of any of the following diseases:

• Any clinically significant comorbidity, as judged by the investigator.
• Clinical signs of active infection found at screening.
• Previous malignancy within the past 5 years.
• Acute or chronic bronchospastic disease within the past 3 years.
• Subject who are currently suffering from any medical condition.
• Subjects who have undergone organ transplantation.
• Received immunosuppressive therapy within 6 months prior to randomization.
• Received any biological product within 90 days or 5 half-lives (for other study drugs), whichever is longer, prior to randomization, or participated in another clinical study and received a study drug.
• Received any drug within 4 weeks prior to randomization.
• Subjects who had an immunization within 4 weeks prior to randomization; subjects who are scheduled to have an immunization during the study or within 4 weeks after the end of study.
• Donated or lost 400 mL or more blood, or received transfusion of blood or any blood product within 60 days prior to randomization.
• Subjects who are smokers or have used tobacco or nicotine-containing products within 3 months prior to randomization.
• Subjects who regularly consumed alcohol within 3 months prior to screening, or who had consumed alcohol after screening and before administration.
• Subjects who had been exposed to a tuberculosis (TB) patient within 6 months prior to randomization.
• Subjects who had drug abuse or a positive urine drug screen within 12 months prior to randomization.
• Pregnant or lactating women.
• Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test result, or clinically significantly abnormal syphilis serology test result.
• History of immunodeficiency disease, including clinically significantly abnormal HIV antibody test result.
• Clinically significantly abnormal vital signs, physical examination, chest radiography, electrocardiogram , or laboratory tests , as judged by the investigator.
• In the investigator's judgment, may increase the risk to the subject.