Novel coronavirus pneumonia(COVID-19)
Conditions
Interventions
300 mg dose group:I.v
900 mg dose group:I.v
1800 mg dose group:I.v
3000mg dose group:I.v
placebo group:I.v
Sponsors
Shulan(Hanzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged 18-45 years (including cut-off values) 2) Male subjects should weigh no less than 50.0 kg, female subjects should weigh no less than 45.0 kg, and the upper limit of acceptable weight is 80.0 kg.Body mass index (BMI) = body weight (kg)/height 2 (m2), with a BMI in the range of 18.0-28.0 kg/m2 (including critical values); 3) Physical examination, vital signs, laboratory examinations and other auxiliary examinations (frontal and lateral chest X-ray, abdominal B-ultrasound, 12-lead electrocardiogram, etc.) are normal or abnormal with no clinical significance; 4) Subjects (including partners) have no plans to become pregnant within 6 months from the time they signed the informed consent to the administration of the study drug and voluntarily take effective contraceptive measures; 5) The subjects can understand the research content and voluntarily sign the informed consent; at the same time, they can complete the research according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1) Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, have a history of contact with new coronavirus confirmed cases or suspected cases within 14 days before signing the informed consent form, or have travel experience in areas with high epidemic incidence or overseas;or infect or carry new coronavirus. 2) Patients with clinically significant abnormalities in the cardiovascular system, respiratory system, digestive system, endocrine system (diabetes), nervous/mental system, blood and lymphatic system (immune system deficiency), and skeletal muscle system confirmed by the researcher ; 3) Those with positive results of any of the hepatitis B surface antigen qualitative [HBsAg], hepatitis C virus antibody [Anti-HCV], human immunodeficiency virus [HIV] antigen-antibody combined detection, and Treponema pallidum specific antibody assay [TP-ELISA]; 4) Those who are known to have a history of allergies to the test drugs or excipients, or have allergies; 5) Those who have a history of vaccination within 3 months before screening, or who have any vaccination plans during clinical trials; 6) Those who received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid therapy within 5 years before screening; 7) Have taken any over-the-counter, prescription, traditional Chinese medicine or vitamin within 1 month before screening; 8) Those who plan to operate during the trial; 9) Those who have a history of drug abuse or a positive urine drug screening test within 12 months before screening; 10) Regular drinkers within 6 months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or who cannot be guaranteed to give up during the trial Alcoholic drinkers, or those with a positive breath test for alcohol; 11) Those who smoked =5 cigarettes per day in the 3 months before screening or those who cannot guarantee to give up smoking during the trial; 12) Those who have participated in clinical trials of other drugs within 3 months before screening (the last visit of the last trial is the start time); 13) Those who donated blood or lost blood =450 mL within 3 months before screening; 14) Those who received =2 units of blood products within 3 months before screening; 15) Those who use tobacco, alcohol or caffeinated beverages, or strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion within 24 hours before and during the test; 16) Women who are pregnant or breastfeeding, or those who have a positive pregnancy test result before the test;Male or female subjects who cannot use a medically approved non-drug contraceptive method during the trial as required by the investigator, or who have a sperm/egg donation plan (from the time of signing the informed consent form until the end of the trial) within 6 months); 17) Difficulty in venous blood collection or fainting of needles; 18) Those who have special requirements for diet, cannot abide by the provided diet and corresponding regulations, cannot avoid eating xanthine-containing beverages (coffee, tea, etc.) or food (animal liver), or cannot avoid eating grapefruit and grapefruit during the test. , mango and other fruits or juices that may affect metabolism; 19) Researchers consider that they are not suitable to participate in this clinical trial (such as infirmity, poor compliance,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| F61 in plasma;The overall positive rate of anti-drug antibodies,positive ratio at different detection times, and antibody neutralization ability of positive samples;AE/SAE;physical examination;laboratory test;vital signs; | — |
Countries
China
Contacts
Public ContactGuiling Chen
Outcome results
None listed