novel coronavirus-infected pneumonia
Conditions
Interventions
Test group:HY3000 nasal spray, single dose, nasal spray
Test group:HY3000 nasal spray, q12 for 7 days
Control group:HY3000 nasal spray placebo, single dose, nasal spray
Control group:HY3000 nasal spray placebo, q12 for 7 days
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who voluntarily sign a written informed consent before the trial; 2. Healthy volunteers aged 18-40 years (based on the date of signing the informed consent form) (single sex ratio >= 1/3; 3. Body weight: female weight >= 45 kg, male weight >= 50 kg,and calculated body mass index (weight (kg)/height 2 (m2)) is within the range of 19.0 to 26.0 (including the threshold value).
Exclusion criteria
Exclusion criteria: 1. Subjects with history of chronic or serious diseases such as neurological/mental, respiratory system, cardiovascular and cerebrovascular system, digestive tract system, blood and lymphatic system, urinary system, endocrine system, immune system diseases, or any other disease or physical conditions that may affect the research results; 2. Subjects with allergic constitution: used to or currently have atopic allergology with clinically significanence, hypersensitivity or anaphylaxis, including being allgeric to known or suspected certain component of the study drug; 3. Subjects with any past or present medical history that may affect the safety of the trial or the in vivo process of the drug, especially those who have any nasal disease that affects drug absorption: (1) History of long-term nasal congestion, runny nose, nasal itching, headache, epistaxis,ect.; (2) Asthma, aspirin stress response, chronic respiratory diseases, etc.; (3) History of nasal surgery, trauma, allergic rhinitis, chronic rhinitis, sinusitis, severe deviated nasal septum, etc., and with clinical significance considered by the investigator; 4. Subjects with a history of drug abuse; 5. Subjects who have undergone surgery within 3 months before screening or plan to have surgery during the trial, or who have undergone surgery that will affect drug distribution, metabolism, and excretion; 6. Subjects who have taken any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products within 2 weeks before screening and enrollment; 7. Subjects who have used any drugs that inhibit or induce liver metabolism of drugs within 28 days before screening (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 8. Subjects who have had dragon fruit, mango, grapefruit or food and drinks prepared from them, or food or drink containing xanthine, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that affect drug absorption, distribution, metabolism, and excretion; 9. Subjects who have been administered with drugs in clinical trials of other drugs or devices within 3 months before screening or plan to participate in other clinical trials during the research period; 10. Subjects who have donated blood or blood products or blood loss >= 400 mL within 3 months before screening or plan to do the above things during the study period (except menstrual bleeding in women); 11. Positive for any of the following items: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immune syndrome antibody (Anti-HIV) and anti-Treponema pallidum antibody (TP-Ab); 12. Subjects who smoked more than 5 cigarettes on average per day within 3 months before screening, and who could not stop using any tobacco products at least 48 hours before administration or during the trial; 13. The average weekly alcohol consumption in 3 months before screening is more than 14 units (1 unit of alcohol is about 360 mL beer or 45 mL spirits with an alcohol content of 40% or 150 mL wine), or have taken any alcoholic products within 24 hours before check-in , or have a positive alcohol screen, or who cannot abstain from alcohol during the test; 14. Subjects who have drank too much tea, coffee and/or caffeinated beverages (average of more than
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of adverse events and serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| elimination half life;Mean retention time in the body;Area under the drug-time curve;apparent volume of distribution; | — |
Countries
China
Contacts
Public ContactHongzhou Lu
Shenzhen Third People's Hospital
Outcome results
None listed