Clinical Research Directory

Inclusion Criteria: 1. Participants who are able to communicate well with the investigator, understand and comply with study requirements, voluntarily participate in the study, and are able to read and sign the informed consent form (ICF); 2. Healthy male or female participants aged 18-55 years (inclusive); 3. At screening, judged by the investigator to be in good health based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests; 4. Male participants with body weights ≥ 50 kg, female participants with body weights ≥ 45 kg, and body mass indexes (BMIs, inclusive): 18-30 kg/m2; 5. Female participants of childbearing potential must have a negative pregnancy test at screening and Day -1; 6. Female participants of childbearing potential or male participants with female partners of childbearing potential must agree to use a highly effective contraception during the study period (from signing the ICF) until 6 months after the dose of the study drug; they must have no plans for pregnancy or donation of sperm/eggs during the study period until 6 months after the dose of the study drug. 7. Participants must be vaccinated against Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenzae type B infections within 5 years but at least 2 weeks prior to the administration of the study drug. If already vaccinated, the proof/document of vaccination must be provided. Exclusion Criteria: 1. With a specific history of allergies (such as asthma, urticaria, and eczema) or known to have multiple allergies (to 3 or more substances), or those with a known history of allergies to the investigational drug or its excipients, or those with current allergic conditions (assessed through interrogation), as judged by the investigator; 2. Any significant medical conditions (e.g., involving central nervous, cardiovascular, digestive, respiratory, urinary, hematological, reproductive, immunological, endocrine systems, or psychiatric disorders) deemed unsuitable for participation in the study by the investigator; 3. Special dietary requirements and cannot follow the study standardized meals (e.g., lactose intolerance, dysphagia); 4. Participants with known or persistent psychiatric disorders that may interfere with participation in the study and require pharmacological intervention, as determined by the investigator, including but not limited to schizophrenia, bipolar disorder, or serious depression; 5. Participants with confirmed or suspected presence of active viral, bacterial, fungal, or parasitic infections within 1 month before the screening; 6. Participants with a history of recurrent or chronic infections;