Novel coronavirus infection
Conditions
Interventions
Experimental group :20mg YKYY017 drug, following aerosol inhalation by nebulizer, twice a day: once in the Day1 morning, once in the D3 evening, and for Day4 to Day7, twice a day at morning and evenin
Control group:20mg YKYY017 placebo, following aerosol inhalation by nebulizer, twice a day: once in the Day1 morning, once in the D3 evening, and for Day4 to Day7, twice a day at morning and evening
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the ICF; 2. At the time of signing the ICF, healthy volunteers aged 18~45 years old (including the upper and lower limits), both male and female; 3. At screening, the weight of male >=50 kg, female >=45 kg, and body mass index (BMI) of 19~26 kg/m^2 (including upper and lower limits); 4. Females of childbearing potential must have a negative serum ß-chorionic gonadotropin (ß-HCG) pregnancy test result at screening; All male and female subjects of childbearing potential agree to use a reliable method of contraception (abstinence, prior ligation, hormonal and/or barrier methods) for the duration of the trial and for at least 90 days after inhalation of the trial drug; Male subjects agree not to engage in sperm donation for the duration of the trial and for 90 days after inhalation of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Those who have been enrolled as subjects in any clinical trial within 3 months before screening; 2. Patients with 12-lead ECG examination results judged by the study doctor to be abnormal and clinically significant, or those with corrected QTc interval =450ms; 3. Previous or current history of any disease that may affect the safety of the subject to participate in the trial or the in vivo process of the study drug, including: clear history of blood system (such as hemolytic reaction), circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, psychiatric abnormalities and metabolic disorders, or other diseases that are not suitable for participating in clinical trials; 4. Those who have undergone major surgery within 3 months prior to screening, or those who have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug, or those who plan to undergo surgery during the trial; 5. Have used or are using any prescription drugs or over-the-counter drugs within 2 weeks before screening; and those who have taken functional vitamins, health products or Chinese herbal products; 6. Those with a history of drug allergies, or a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (such as allergies to two or more drugs, foods and pollen); 7. Those who have difficulty in venous blood collection or cannot tolerate venipuncture or have a history of dizziness and blood sickness; 8. Those who have lost blood or donated more than 400 mL of blood within 3 months before screening (excluding female menstrual blood loss), or who intend to donate blood during the trial or within 1 month after the end of the trial; 9. Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 8 cups per day, each cup of 250 mL) within 6 months before screening; 10. Those who have ingested any grapefruit or caffeinated beverages or foods (such as grapefruit juice, coffee, strong tea, chocolate, caffeinated carbonated drinks, cola, cocoa, etc.) within 48 hours before screening; 11. Those who cannot eat or have difficulty swallowing, or have special requirements for diet and cannot comply with a uniform diet; 12. Those who smoked more than 5 cigarettes per day on average in the 3 months before screening; or those who cannot stop smoking during the trial; 13. Those who regularly drink alcohol (i.e., more than 14 standard units of alcohol per week for women and more than 21 standard units per week for men (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) within 6 months prior to screening) or who cannot abstain from alcohol during the trial; or a positive alcohol breath test; 14. Those with a history of drug abuse/drug use in the past; or those who have a positive drug abuse screening result (including benzodiazepines, methamphetamines, cocaine, morphine, ketamine, tetrahydrocannabinolic acid); 15. Those who have a positive test result of any one of the hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) during the screening period; 16. Those who have been judged by the research doctor to be abnormal and clinically significant in the results of physical examination, vital signs examination, and laboratory examination (blood routine, urine routi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters, PK parameter;Immunogenicity; | — |
Countries
China
Contacts
Public ContactCui Gang
China-Japan Friendship Hospital
Outcome results
None listed