COVID-19
Conditions
Interventions
Drug-SAD phase:YKYY017 Inhalation Solution
Control-SAD phase:YKYY017 placebo
Drug-MAD phase:YKYY017 Inhalation Solution
Control-Placebo:YKYY017 Placebo
Sponsors
China-japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Are capable of giving informed consent form (ICF) and complying with study procedures; 2.Are between the ages of 18 and 45 years (inclusive) at the time of signing the ICF; 3.Body Mass Index (BMI) of 19 to 26 kg/m2 inclusive and body weight not less than 45 kg for female, 50 kg for male subjects at screening; 4.Female subjects have a negative blood pregnancy test (serum ß-human chorionic gonadotropin). All male and female participants of child-bearing potential agree to use a reliable contraceptive method (abstinence, previous ligation, hormonal and/or barrier methods) during the trial and until 90 days after the last study drug. Male participants agree not to donate sperm during the trial and until 90 days after the last study drug.
Exclusion criteria
Exclusion criteria: 1.Subjects were enrolled in any other clinical trials within 3 months before screening; 2.Subjects have an abnormal result judged by the physician to be clinically significant in the 12-lead electrocardiogram, or the adjusted QTc interval value =350mcs or =450mcs; 3.Subjects with a medical history that may affect the safety of the participant in the trial or the process of the drug in body, including diseases of the hematological system (e.g., hemolysis), circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental and metabolic disorders, or other medical conditions that are not suitable for participation in the clinical trial; 4.Subjects underwent major surgery within 3 months before screening, or had a surgery that might significantly affect the process of the drug in body or safety evaluation of the study drug, or plan to take a surgery during the trial; 5.Subjects took any prescription or OTC medication, vitamins, health supplements, and/or Chinese herbal products within 2 weeks before screening, or are taking medicine during the trial; 6.Subjects with any known history of drug allergy or any hypersensitivity disease (asthma, urticaria, eczema, etc.), or allergic constitution (such as be allergic to two or more kind of drugs, foods, and pollen); 7.Subjects have difficulty in venous blood specimen collection or are intolerable to venipuncture, or have a history of needle and/or blood phobia; 8.Subjects had blood lost or donated blood more than 400 mL (excluding menstrual blood loss in women) within 3 months, or intend to donate blood during this trial or within 1 month of the end of the study; 9.Subjects overconsume tea, coffee, or caffeine-contained beverages (more than 8 cups of 250 mL per cup per day on average) within the 6 months before the screening; 10.Subjects consume any beverage or food containing grapefruit or caffeine (such as grapefruit juice, coffee, strong tea, chocolate, caffeine-contained carbonated beverages, cola, cocoa, etc.) within 48 hours before screening; 11.Subjects are unable to eat or have dysphagia, or have special dietary requirements, therefore are unable to follow a uniform diet; 12.Subjects smoke regularly more than 5 cigarettes per day within 3 months before the screening, or are unable to stop using any tobacco products during the study; 13.Subjects take alcohol regularly within 6 months before the screening [i.e., more than 14 standard units per week for female or 21 standard units per week for male participants (1 standard unit containing 14g alcohol, e.g., 360 mL beer or 45 mL 40% spirits or 150 mL wine)], or unable to abstain from alcohol during the study , or have a positive breath alcohol test; 14.Subjects with a history of substance abuse/ illegal drug use, or have a positive substance abuse test (including benzodiazepines, methamphetamines, cocaine, morphine, ketamine, tetrahydrocannabinol); 15.Subjects have a positive result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), anti-Treponema pallidum antibody (TP-Ab) or HIV antibody and antigen (HIV-Ab/Ag); 16.Subjects have an abnormal result judged by the physician to be clinically significant in physical examination, vital signs examination, or laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.); 17.Subjects have an abnormal result judged by the physician to be clinically significant in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter;Immunogenicity; | — |
Countries
China
Contacts
Public ContactJintong Li
China-Japan Friendship Hospital
Outcome results
None listed