Bronchial Asthma
Conditions
Interventions
Dosage 1 group (Test drug):Single nebulised inhalation test drug dose 1 (vs placebo)
Dosage 1 group (Placebo):placebo (Single nebulised inhalation test drug dose 1)
Dosage 2 group (Test drug):Single nebulised inhalation test drug dose 2 (vs placebo)
Dosage 2 group (Placebo):placebo (Single nebulised inhalation test drug dose 2)
Dosage 3 group (Test drug):Single nebulised inhalation test drug dose 3 (vs placebo)
Dosage 3 group (Placebo):placebo (Single nebulised inhalation test drug dose 3)
Dosage 4 group (Test drug):Single nebulised inhalation test drug dose 4 (vs placebo)
Dosage 4 group (Placebo):placebo (Single nebulised inhalation test drug dose 4)
Dosage 5 group (Test drug):Single nebulised inhalation test drug dose 5 (vs placebo)
Dosage 5 group (Placebo):placebo (Single nebulised inhalation test drug dose 5)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily signed the informed consent form before the trial and fully understood the content, process and possible adverse effects of the trial; voluntarily participated and were able to complete the study in accordance with the requirements of the trial protocol; 2. Healthy Chinese subjects aged 18 to 50 years (including the cut-off value), regardless of gender; 3. Weight >= 50 kg for male; weight >= 40 kg for female; with an upper weight limit of 90.0 kg. BMI within the range of 18.0-26.0 kg/m2 (including cut-off values); 4. No clinically significant abnormality in Physical examination, vital signs, laboratory tests and other ancillary tests (chest imaging, abdominal ultrasound, 12-lead ECG, etc.) in the judgment of the investigator; 5. Subjects (male subjects and females of childbearing age) and their sexual partners are willing to use medically approved non-pharmaceutical contraception from 2 weeks prior to screening to 6 months after dosing and have no plans to donate sperm/eggs.
Exclusion criteria
Exclusion criteria: 1. Those with a history of any clinically significant disease of the cardiovascular, respiratory, digestive, endocrine (e.g., diabetes), neurological/psychiatric, haematological and lymphatic (immune system deficiencies), skeletal-muscular systems, as identified by the investigator, or any other disease that may interfere with the results of the trial; 2. Those with any clinically significant major illness, infectious disease (e.g., cellulitis, abscess or systemic infection such as sepsis) or a history of clinically significant opportunistic infections (e.g. invasive candidiasis or Pneumocystis carinii pneumonia) within 3 months prior to screening; 3. Persons with parasitic (helminthic) infection within 6 months prior to screening; 4. Those with a history of active tuberculosis; or any current symptoms, signs, laboratory tests, etc., suggesting the possibility of latent tuberculosis infection or active tuberculosis; 5. Those who have undergone surgery within 6 months prior to screening or those who plan to have surgery during the trial; 6. Those who have taken any over-the-counter drugs, prescription drugs, herbal medicines, vitamins or supplements within 14 days or 7 drug half-lives (whichever is longer) prior to screening; 7. Those who have received chemotherapy, radiotherapy or immunosuppressive therapy within 5 years prior to screening; 8. Those who have a significant history of substance abuse or who are positive for substance abuse screening within 12 months prior to screening; 9. Persons with a known allergy to the components of the study drug and any of its components, or to other similar drugs; 10. Those who have received a live or attenuated vaccine within 4 weeks prior to enrollment, or those who plan to receive a vaccine during the trial; 11. Persons who have donated or lost >= 400 mL of blood, or received a blood transfusion or used blood products within 3 months prior to screening; 12. Those who have been enrolled in a clinical trial of another drug within 3 months (the last visit of the last trial is counted as the start time) or within 5 drug half-lives (whichever is longer) prior to screening; 13. Those who have difficulties with intravenous blood collection or who suffer from dizziness from needles and nebulised inhalation administration; 14. Persons who smoked an average of more than 5 cigarettes per day during the 3 months prior to screening or who were unable to stop using any tobacco-based products during the trial; 15. Regular drinkers of alcohol within the 6 months prior to screening, for males who consume more than 25 grams of alcohol per day, equivalent to 750 ml of beer, or 250 ml of wine, or 75 grams (1.5 taels) of 38 white wine, or 50 grams (1 tael) of high white wine; for females who consume more than 15 grams of alcohol per day, equivalent to 450 ml of beer, or 150 ml of wine, or 50 grams (1 tael) of 38° white wine or who cannot guarantee to abstain from alcohol consumption during the test, or who have a positive blood alcohol test; 16. Women who are pregnant or breastfeeding, or who have a positive blood pregnancy test prior to the trial; 17. C-reactive protein > the upper limit of normal at the time of screening; 18. Persons with positive results for any of the tests for hepatitis B virus surface antigen (HBsAg), antibodies to hepatitis C virus (Anti-HCV), antibodies to human immunodeficiency virus (HIV), or antibodies to syphilis spirochetes; 19. Acute illness or concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;Vital signs;Physical examination;12-lead electrocardiogram (ECG);local (oropharyngeal) tolerance assessment;blood routine;urine routine;blood biochemistry;coagulation function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;ADA test;Nab test; | — |
Countries
China
Contacts
Public ContactWei hu
The Second Hospital of Anhui Medical University
Outcome results
None listed