Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Group 1:Atomization treatment, 0.2mg IFN-k/ 0.5 mg TFF2
Group 2:Atomization treatment, 1mg IFN-k/ 2.5 mg TFF2
Group 3:Atomization treatment, 2mg IFN-?/ 5 mg TFF2
Group 4:Atomization treatment, 4mg IFN-?/ 10 mg TFF2
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) The subject fully understands the purpose, nature, method and possible adverse reactions of the study, volunteers to be a subject, and signs the informed consent prior to the commencement of any study procedure, and warrants that he/she will participate in any study procedure; 2) The subject can have good communication with the researcher, and understand and comply with the requirements of this study; 3) Subjects have no history of chronic or serious diseases such as cardiovascular, liver, kidney, respiratory, blood, lymphatic, endocrine, immune, mental, neurological, gastrointestinal system and other diseases, and are in good general health condition; 4) Subjects (including male subjects) have no pregnancy plan during the screening period and in the next 6 months and are willing to take effective contraceptive measures and have no sperm or egg donation plan, among which non-drug contraceptive measures should be adopted voluntarily during the test; 5) Male or female subjects aged from 18 to 45 years (including 18 and 60 years old); 6) Male weight >=50.0kg, female weight >=45.0kg;Body mass index (BMI) was within the range of 19.0~26.0 kg/m2 (including the critical value); 7) Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, four items of blood transfusion, coagulation function, pregnancy examination (female), alcohol and drug screening, etc.), 12-lead electrocardiogram, chest X-ray examination and abdominal B-ultrasound examination, and the results show no abnormality or no clinical significance.
Exclusion criteria
Exclusion criteria: 1) Health status: medical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental and metabolic abnormalities, bone and other diseases with clinical significance; 2) Allergy to biological agents or any drug components;Those who had a history of allergy and were judged unfit for inclusion by the researcher; 3) Those who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, and those who have undergone surgery that may affect drug absorption, distribution, metabolism and excretion; 4) Those who cannot tolerate venipuncture or have a history of fainting needles and blood; 5) Screening those with a history of drug abuse in the previous 6 months; 6) Screening for drug use in the previous 3 months; 7) Screening blood donation including component blood or massive blood loss (>=200mL) within 3 months before receiving blood transfusion or using blood products; 8) The subject (female) is pregnant or lactating during the screening period or during the test; 9) Subject has any family planning or sperm or egg donation plan during the screening period and in the next 6 months; 10) Use any prescription drug, non-prescription drug or Chinese herbal medicine within 2 weeks before screening; 11) Screening those who have received vaccination within 4 weeks prior to the study or plan to receive vaccination during the study period; 12) Screening for smokers who had smoked more than 5 cigarettes per day in the previous 3 months, or could not stop using any tobacco products during the study period; 13) Screening of persons who had consumed more than 14 units of alcohol (1 unit of alcohol ˜360 mL beer or 45 mL spirits of 40% alcohol or 150 mL wine) per week during the first 3 months, or who were unable to abstain from alcohol during the trial period; 14) Those who have special requirements on diet and cannot accept a unified diet; 15) Screening those who have participated in the drug clinical trial and used the experimental drug within the previous 3 months; 16) Received immunosuppressive agents or monoclonal antibodies before screening; 17) For abnormalities of vital signs with clinical significance, the range of normal values (including critical values) shall be referred: sitting systolic blood pressure 90~139mmHg, diastolic blood pressure 60~89mmHg, pulse 60-100 times/min, body temperature (ear temperature) 35.4~37.7 degree C, respiration 16~20 times/min. The specific conditions shall be determined by the researchers; 18) Laboratory examination and auxiliary examination of any item abnormal and clinically significant as determined by the researcher; 19) One or more tests of hepatitis B virology index, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-treponema pallidus specific antibody have clinical significance; 20) Female subjects with positive urine or blood pregnancy test results during screening period; 21) Alcohol breath test results greater than 0.0mg/100mL or drug screening positive (morphine, meth (methylamphetamine), ketamine, ecstasy (dimethylenedioxymethamphetamine), cannabis (tetrahydrocannabinol); 22) Patients with acute illness from screening to -1 day of admission; 23) take any prescription drug, non-prescription drug or Chinese herbal medicine from screening to one day of hospitalization; 24) The investigator determined that the subjects had any inelig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of atomization (IFN- +TFF2) combined with single dose in healthy volunteers;Vital signs;Blood drug concentration; | — |
Countries
China
Contacts
Public ContactJianqing Xu/ Yan Liu
Shanghai Public Health Clinical Center
Outcome results
None listed