A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects

Inclusion criteria

• Males aged 18 to 45;
• Body Mass Index (BMI) is 19.0~28.0 kg/m2, and body weight is 50.0~80.0kg ;
• Signing informed consent form before the trial and having a full understanding of the trial content, process and possible adverse reactions;
• Able to complete the study according to the requirements of the study protocol.

Exclusion criteria

• Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
• Those with a history of autoimmune diseases;
• Those with a history of malignant tumor, unless it is a skin squamous cell carcinoma, basal cell carcinoma or cervical cancer in situ that has been successfully resected and has no evidence of metastasis;
• Regular drinkers within 6 months prior to screening;
• Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
• Those who have used anti-PD-1/PD-L1 or/and anti-CTLA-4 drugs in the past;
• Those who have been vaccinated with live or attenuated-live vaccines within 3 months before screening, or who are expected to receive vaccines during the study period;
• Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
• Those who received major surgery or hospitalization due to illness within 3 months before screening;
• Abnormal laboratory tests with clinical significance at screening;
• Positive drug screening result;
• Have a childbirth plan within 6 months from the screening period to the trial drug administration, or who are unwilling to take the contraceptive measures specified in the protocol during the trial period.