Novel coronavirus pneumonia(COVID-19)
Conditions
Interventions
Experimental group 1:Inject 2B11 300mg
Experimental group 2:Inject 2B11 900mg
Experimental group 3:Inject 2B11 1800mg
Experimental group 4:Inject 2B11 3000mg
Control group:Inject placebo
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-45 years (including the cut-off value); 2. Male subjects should weigh at least 50.0 kg and female subjects should weigh at least 45.0 kg. The upper limit of acceptable weight is 80.0 kg. Body mass index (BMI) = weight (kg)/height ^2 (m^2), in the range of 18.0-28.0 kg/m^2 (including the threshold); 3. Physical examination, vital signs, laboratory examination and other auxiliary examinations (antero-lateral chest radiographs, abdominal B-ultrasound, 12-lead electrocardiogram, etc.) are normal or abnormal without clinical significance; 4. The subject (including the partner) has no pregnancy plan and voluntarily takes effective contraceptive measures within 6 months after signing the informed consent to the study drug administration; 5. Subjects can understand the study content and sign the informed consent voluntarily; At the same time, can complete this study according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1. Those who have been diagnosed with COVID-19 cases or suspected cases, had contact history with confirmed COVID-19 cases or suspected COVID-19 cases within 14 days before signing the informed consent form, or had travel experience in high-prevalence areas or overseas; Or COVID-19 infected or carriers; 2. Patients with positive results of any one of HBsAg, hepatitis C virus antibody [Anti-HCV], human immunodeficiency virus [HIV] antigen combined detection, treponema pallidum specific antibody detection [TP-ELISA]; 3. Known allergic history to test drugs or excipients, or allergic constitution; 4. Vaccination history in the 3 months prior to screening, or any vaccination schedule during the clinical trial; 5. Patients who received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid therapy within 5 years prior to screening; 6. Taking any over-the-counter, prescription, traditional Chinese medicine or vitamin within 1 month before screening; 7. Patients who planned surgery during the trial; 8. Patients with a history of drug abuse or positive urine drug screening in the 12 months prior to screening; 9. Regular drinkers in the six months prior to screening, i.e., those who consumed more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits 40% alcohol or 150 mL wine), or who could not guarantee abstaining during the test period, or who tested positive for alcohol breath test; 10. Smokers who smoked at least 5 cigarettes a day in the 3 months before screening or could not guarantee to give up smoking during the test period; 11. Participated in clinical trials of other drugs within 3 months prior to screening (the last visit time of the previous trial was calculated as the start time); 12. Blood donation or blood loss >=450 mL within 3 months prior to screening; 13. Receiving >=2 units of blood products within 3 months prior to screening; 14. Use of tobacco, alcohol or caffeinated beverages, or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism or excretion within 24 hours before and during the test; 15. Patients who are pregnant or breastfeeding, or who have a positive pregnancy test before the test; Or have a sperm/egg donor plan (from signing the informed consent to 6 months after the end of the trial); 16. Patients with difficulty in venous blood collection or fainting needle and fainting blood; 17. Patients who have special dietary requirements, cannot comply with the provided diet and corresponding regulations, cannot avoid xanthine-containing drinks (coffee, tea, etc.) or food (animal liver) during the test, or cannot avoid eating grapefruit, grapefruit, mango and other fruits or juices that may affect metabolism; 18. Those who are considered unfit to participate in this clinical trial by the researchers (such as weak body, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2B11 in plasma;the overall positive rate of anti-drug antibodies;incidence of adverse events/serious adverse events;physical examination;vital signs;laboratory test;the proportion of positives at different test times;antibody neutralization ability of positive sample; | — |
Countries
China
Contacts
Public ContactChen Guiling
Outcome results
None listed