COVID-19
Conditions
Interventions
Test group:F61 nasal spray
Sponsors
Wuhan Infectious Diseases Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-45 years (including the critical value); 2. The weight of male subjects shall not be less than 50.0 kg, and that of female subjects shall not be less than 45.0 kg. The upper limit of acceptable weight is 80.0 kg. Body mass index (BMI)=weight (kg)/height 2 (m2), and the BMI is within the range of 18.0-28.0 kg/m2 (including the critical value); 3. Physical examination, vital signs, laboratory examination (blood routine examination, blood biochemistry, blood coagulation function, urine routine examination, virology examination, urine drug screening, female pregnancy examination), alcohol breath test and other auxiliary examinations (12 lead ECG, chest radiograph) are normal or abnormal without clinical significance; 4. Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures within 6 months from signing the informed consent to the administration of the study drug; 5. Subjects can understand the research content and voluntarily sign the informed consent form; At the same time, the research can be completed according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Participated in other drug clinical trials (including medical device clinical trials) within 3 months before screening; 2. (Interview) Those with a history of COVID-19 infection or current disease within 1 month before screening; 3. (Interview) Those with acute infectious diseases within 14 days before administration; 4. (Interview) Patients with systemic diseases confirmed by the researcher, including but not limited to: cardiovascular system, respiratory system, digestive system, endocrine system (such as diabetes), nervous/mental system, blood and lymphatic system (immune system defects), skeletal muscle system, metabolic abnormalities and other diseases with clinical significance; 5. (Interview) Those who are known to have a history of allergy to the test drug or excipient ingredients, or have allergic constitution, especially those who are known to be allergic to pollen or protein foods or have respiratory allergic diseases; 6. (Interview) Those who have received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid treatment within 5 years before screening; 7. (Inquiry) Those who have used any drugs (including Chinese herbal medicine) or health products, received vaccination or planned to be vaccinated during the trial within 2 weeks before screening; 8. (Inquiry) Those who have a history of drug abuse within 6 months before screening; 9. (Inquiry) Those who have used drugs within 3 months before screening; 10. (Inquiry) Those who donate blood within 3 months before screening, including component blood or massive blood loss (= 400mL), receive blood transfusion or use blood products, and those who plan to donate blood during the trial; 11. (Inquiry) Those who can not tolerate venous puncture or indwelling needle for blood collection, and have a history of needle and blood sickness; 12. (Interview) Those who smoked = 5 cigarettes a day 3 months before screening or could not guarantee to give up smoking during the trial; 13. (Inquiry) Those who drink more than 14 units (1 unit=17.7mL ethanol, that is, 1 unit=357mL beer with 5% alcohol, 43mL Baijiu with 40% alcohol, or 147mL wine with 12% alcohol) per week in the three months before screening, or who cannot abstain from drinking during the test; 14. (Interview) Those who cannot accept or tolerate nasopharynx swab collection; 15. (Interview) Pregnant or lactating women, or those with positive pregnancy test results before receiving test drugs; Male or female subjects could not take a medically approved non drug contraceptive measure during the trial according to the requirements of the researcher, or had sperm/egg donation plan (from signing the informed consent to the end of the trial within 6 months); 16. (Interview) Any nasal mucosa erosion, nasal septum ulcer or nasal septum perforation or other nasal diseases that may affect drug deposition in the nose, such as acute or chronic drug rhinitis, nasal tumor or nasal septum abnormality; Those who had undergone sinus surgery or had nasal trauma not yet fully healed within 3 months before screening; Local or systemic fungal, bacterial, viral or parasitic infections on the face that have not been cured and still need continuous treatment within 4 weeks before screening; 17. Those who may not be able to complete the study due to other reasons or who are judged by the investigator to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE/SAE occurrence;12 lead ECG results;Physical examination results;Vital signs and laboratory results; | — |
Secondary
| Measure | Time frame |
|---|---|
| F61 blood concentration; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Infectious Diseases Hospital
Outcome results
None listed