COVID-19
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female aged >=18 years when signing the informed consent form; 2. Body weight is between 50 and 90 kg, and body mass index (BMI) is between 19 and 26kg/m2 (including boundary value); 3. Agree not to participate in other studies until the end of the 29th day of the study.
Exclusion criteria
Exclusion criteria: 1. Allergic to the study drugs or their ingredients, or allergic constitution: if allergic to two or more drugs or food; Or have allergic history to similar drugs; 2. Screening for diseases with abnormal clinical manifestations that need to be excluded, including but not limited to the mental nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone and other systemic diseases and previous history of malignant tumors; 3. Abnormal and clinically significant results of physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, etc.) and have an impact on the evaluation of this test; Among them, fasting blood glucose, LDL-C, triglyceride of any item >=1.5 ULN cannot be enrolled; 4. Abnormal ecg examination with clinical significance, PR interval >=210ms, QRS>=120ms, QTcF>=450ms, or previous clinical significance of ATRIoventricular block; 5. Having any known bacterial, viral, fungal, parasitic or other infection or any infectious disease requiring anti-infective treatment or hospitalization within 4 weeks before the test, which may affect the test results as determined by the clinician; 6. Patients who have difficulty in blood collection or cannot tolerate vein puncture and have a history of fainting needles and blood; 7. Blood donation or blood loss >=200mL within 3 months before the test, or plan to donate blood or blood composition within 3 months after the study; 8. Those who smoked more than 5 cigarettes per day in the 3 months before the test and could not smoke during the whole test period; 9. drink more than 14 units of alcohol (1 unit equal to 360mL beer or 45mL 40% spirits or 150mL wine) per week within 3 months prior to signing the informed consent, or breath test positive for alcohol (breath alcohol >0.0mg/100mL) the day before administration, or cannot abstain during the test; 10. Past long-term excessive consumption (more than 8 cups a day, 1 cup =200mL) of tea, coffee or caffeinated beverages; 11. Used any medicine (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health care products within 14 days before the trial; 12. Having a history of drug abuse/dependence or drug abuse within 1 year prior to the test; 13. Positive detection of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C virus antibody, treponema Pallidum antibody; 14. Women who are pregnant, breastfeeding or planning to become pregnant during the course of the study, and men or women who do not wish to use barrier contraception throughout the study period and for a period of three months after the end of the study; 15. Those who plan to participate in vigorous exercise during the test, including contact or collision exercise; 16. Those who have undergone major surgery within 6 months prior to the study, or plan to undergo surgery during the study period; 17. Those who have participated in any drug clinical trial and taken the experimental drug within 3 months before the trial; 18. Researchers, research centers, sponsors and employees of contract research organizations or related personnel; 19. The researcher believes that the subject has other conditions that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Vital Sign monitoring;Physical Examination;Laboratory Testing;ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;ADA; | — |
Countries
China
Contacts
OncoImmune-Guangzhou, Inc.