XKH001 Injection in Healthy Subjects

Korábbi kezelés

• Subjects with active infections requiring hospitalization or IV antibiotic treatment within 3 months prior to dosing, or bacterial, viral and fungal infections with clinical symptoms within 1 week;
• Subjects who plan to receive live or live attenuated vaccines within 4 weeks prior to dosing or during the study;
• Subjects who have participated in clinical studies of any drug or device within 3 months or 5 half-lives of the investigational product (whichever is longer) prior to dosing;
• Subjects who are allergic to the investigational product or any component of the formulation of the investigational product or have a history of allergy to protein drugs;
• Subjects 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 6 weeks prior to screening or have taken alcoholic products 1 day before dosing;
• Subjects who have a history of abuse of other drugs within 5 years prior to screening, or who have a positive urine drug screen result;
• Subjects who have a smoking history (> 5 cigarettes/day) within 3 months prior to screening;
• Subjects who have blood donation or blood loss of more than 450 mL within 8 weeks prior to screening, or blood donation of more than 200 mL or blood loss of more than 300 mL within 1 month;

Más betegség

• Subjects with clinically significant diseases that may affect the subject's participation in this study within 5 years as judged by the investigator: including but not limited to gastrointestinal, renal, liver, lung, neurological, blood, endocrine, tumor, metabolic, psychiatric or cardio-cerebrovascular diseases, etc.;
• Subjects with history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;
• Subjects with a history of active tuberculosis or subjects with active or latent tuberculosis infection at screening;
• Subjects with positive HBsAg in 5 items of hepatitis B serology (if HBsAg is negative, HBcAb is positive, and HBsAb is negative, HBV DNA quantitative test is required to be performed [the subject will be excluded if the test result is positive]), positive hepatitis C antibody, treponema pallidum antibody, HIV antigen/antibody;

Egyéb

• Pregnant or lactating women;
• Subjects with obstructed venous access or intolerance to venipuncture;
• Subjects who are considered inappropriate for the study by the investigator.

• Healthy subjects who voluntarily sign a written informed consent form (ICF) and are able to complete the study as required by the protocol;
• Male or female subjects aged 18 to 65 years (inclusive);
• Subjects with BMI between 18 and 28 kg/m2 (inclusive);
• Subjects with normal or abnormal but not clinically significant results of vital signs, physical examinations, laboratory tests, 12-lead ECGs and QTcF ≤ 450 ms;
• Subjects who did not use any prescription or over-the-counter medications within two weeks prior to dosing;
• Subjects who agree to have no child-bearing plans and to voluntarily take effective contraception measures during the study and within 6 months after the end of the study.