A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection

Inclusion criteria

• Male or female subjects aged 18 to 45 years (including 18 and 45 years).
• Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value).
• The medical history, physical examination, clinical laboratory tests and other tests related study show no abnormalities, or abnormalities without clinical significance.
• Subjects do not have a pregnancy plan, have no sperm and egg donation plans during the screening period and the next 6 months, and take effective contraceptive measures voluntarily.
• Are willing to follow study procedures, signed informed consent voluntarily, and ensure that he/she will complete the study according to the program requirements.

Exclusion criteria

Prior or current medical conditions:

• Health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities.
• Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
• Those who undergone acute infection within 2 weeks prior to screening.
• Those with abnormalities in pulmonary imaging examination prior to screening and judged to be clinically significant by the investigator.
• Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study.
• Those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
• Those who have a history of drug abuse within 6 months prior to screening.
• Use of illicit drugs within 3 months prior to screening.
• Those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 mL), or blood transfusions or use of blood products.
• Subject (female) who is pregnant or lactating at screening or during the trial.
• Subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months.
• Use of any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
• Those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study.
• Those who have smoked more than 5 cigarettes per day within 3 months prior to screening.
• Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial.
• Those who have special dietary requirements and cannot accept a standard diet.
• Those who have participated in drug or medical devices clinical trials within 3 months prior to screening.
• Those who have previously used immunosuppressants or monoclonal antibodies for any reason.
• Those with abnormal vital signs with clinical significance: diastolic blood pressure≤50 mmHg or ≥90 mmHg, pulse≤50 beats/min or ≥100 beats/min, body temperature (ear temperature) <35.5°C or >37.5°C, respiration>20 breaths/min. The specific situation will be comprehensively determined by the investigator.
• Those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant.
• Those who have one or more clinically significant tests of hepatitis B virological markers, hepatitis C virus antibodies, anti-human immunodeficiency virus antibodies, or anti-Treponema pallidum-specific antibodies.
• Female subjects with a positive blood pregnancy test at screening.
• Alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate], erythroxylin).
• Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.