Respiratory Diseases
Conditions
Interventions
Test group 1:Single Ascending Dose
Control group 1:Single Ascending Dose
Test group 2:Multiple Ascending Dose
Control group 2:Multiple Ascending Dose
Sponsors
The Third Hospital of Changsha
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18-55 years at the time of signing the informed consent, any gender; 2. Male weight >= 50.0 kg, female weight >= 45.0 kg, and BMI between 19.0-28.0 kg/m^2; 3. Voluntarily participate in the clinical study and sign the informed consent; 4. Study participants understand and agree to correctly use the inhalation device required by the study.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history or current condition of chronic or severe diseases affecting the endocrine, urinary, digestive, hematologic and lymphatic, respiratory, cardiovascular, neurological and psychiatric, or immune systems, or other physiological conditions that may interfere with the absorption, distribution, metabolism, or excretion of drugs; 2. Individuals with a clear history of drug-induced liver injury, or those with specific respiratory system, immune system infections, or specific ophthalmic conditions that could affect the assessment of the study; 3. Individuals allergic to any component of this product or with an allergic constitution (referring to allergies to two or more drugs and foods); 4. Individuals with a history of needle or blood phobia, or poor venous access making blood draws difficult; 5. Individuals who have participated in any drug or medical device clinical trial in the 3 months prior to screening, or who are still within 5 half-lives of a drug; 6. Individuals who have previously undergone respiratory system surgery, or have had serious infections, severe trauma, or major surgery within 3 months prior to or during screening; or plan to undergo surgery during the trial or within two weeks after the trial ends; 7. Individuals who have taken any medication or dietary supplements within 2 weeks prior to screening or during screening; 8. Individuals who have used preparations containing corticosteroids within 30 days prior to screening or during screening; 9. Individuals with clinically significant abnormalities in physical examination, pre-transfusion tests, vital signs, laboratory tests, or imaging during the screening period; 10. Individuals with a history of drug abuse or drug dependence within 12 months prior to screening; or testing positive for drug abuse or drugs before enrollment; 11. Individuals with pulmonary function test results showing FEV1 or FVC = 80% of the predicted value; 12. Individuals with clinically significant abnormalities on a 12-lead ECG at screening, or QTcF = 450ms (male) or = 460ms (female); 13. Individuals who smoke =10 cigarettes per day, cannot abstain from smoking during the trial, or test positive for smoking; 14. Individuals with a history of alcoholism, or who drank frequently within 6 months prior to screening, cannot abstain from alcohol during the trial, or have a positive breath alcohol test after admission; 15. Individuals who consumed excessive tea, coffee, or caffeinated beverages within 6 months prior to screening; or who, within 2 weeks prior to screening or during the screening period, consume an average of more than 100g per day of foods rich in xanthine such as chocolate, or more than 100g per day of foods containing grapefruit and/or pomelo, or consumed caffeine-rich foods or drinks (such as coffee, strong tea, chocolate, etc.) or any grapefruit/pomelo-containing foods or beverages within 48 hours prior to screening; 16. Individuals who have donated blood or experienced significant blood loss (more than 400 mL) within 3 months prior to screening or during the screening period, or who plan to donate blood during the study or within 3 months after study completion; 17. Women who are pregnant or breastfeeding; women who used long-acting estrogen or progestin injections or implants within 6 months prior to screening; or women with positive pregnancy test before enrollment; 18. Individuals planning to donate sperm or eggs or become
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Parameters ; | — |
Countries
China
Contacts
Public ContactLi Xin
The Third Hospital of Changsha
Outcome results
None listed