bronchial asthma
Conditions
Interventions
Group S1:Single oral inhalation of LQ036 (dose 1) or placebo
Group S2:Single-dose transoral inhalation of LQ036 (dose level 2) or placebo
Group S3:Single-dose transoral inhalation of LQ036 (dose level 3) or placebo
Group S4:Single-dose transoral inhalation of LQ036 (dose level 4) or placebo
Group S5:Single-dose transoral inhalation of LQ036 (dose level 5) or placebo
Group M1:Transoral inhalation of LQ036 (dose level a) or placebo, QD.
Group M2:Transoral inhalation of LQ036 (dose level b) or placebo, QD.
Group M3:Transoral inhalation of LQ036 (dose level c) or placebo, QD.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subjects sign the informed consent voluntarily before the test, and fully understand the study content, process and possible adverse reactions; Voluntary participation and ability to complete the study as required by the program; 2. Healthy subjects aged between 18 and 45 years (including boundary values) at the time of screening, no gender limit, male and female half; 3. Male subject weight >=50.0kg; Female subjects had a body weight >=45.0kg and a BMI between 18.0 and 26.0kg/m2 (including boundary values); 4. The subjects (male and female with fertility potential) and their sexual partners are willing to have no fertility plan from 4 weeks before screening to 3 months after the last administration of the test drug, voluntarily take effective contraceptive measures, and have no sperm and egg donation plan.
Exclusion criteria
Exclusion criteria: 1. Known allergy to LQ036, any component in the preparation, or other similar drugs; 2. A history of any clinically serious diseases in the blood system, circulatory system, digestive system, respiratory system, urinary system, immune system, endocrine system, malignant tumors (excluding excised and non-recurrent tumors and non-melanoma skin cancer), nervous system and mental disorders (excluding depression without treatment within 6 months) or any other disease or medical condition that may interfere with the results of the test; 3. Patients with abnormalities in physical examination, vital signs detection, 12-lead electrocardiogram, laboratory examination and other abnormalities judged by researchers to be clinically significant; 4. Patients with herpes simplex at the time of screening, or those assessed by researchers as recurrent herpes simplex; 5. Any clinically significant illness, infectious disease (e.g. cellulitis, abscess, or systemic infection (e.g. sepsis), or a history of clinically significant opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within the first 12 weeks of enrollment; Or clinically significant disease or operation occurred within 4 weeks before enrollment; 6. Patients who have been exposed to an endemic area of tuberculosis within 8 weeks prior to screening, or who have a history of latent or active tuberculosis, or whose screening results indicate a possible history of latent or active tuberculosis; 7. C-reactive protein > upper limit of normal; 8. Virological examination (HBsAg, HCV-Ab, HIV-Ab, TP-Ab) found any positive results; 9. Patients who cannot tolerate blood collection by venipunction or dizziness of blood and needle; 10. A history of alcohol abuse within the 1 year prior to screening (i.e., more than 28 standard units per week for men and 21 standard units per week for women, with a standard unit containing 14 grams of alcohol, Such as 360mL beer or 45mL 40% spirits or 150mL wine) or those who cannot stop drinking any alcohol products during the test or who test positive for blood alcohol; 11. Smokers who smoked more than 5 cigarettes per week within 1 year before screening, or who could not stop using any herbal products during the test; 12. Patients with a history of drug abuse in the year prior to screening or who are positive for drug abuse screening (including morphine, methylamphetamine and ketamine); 13. Patients who had used biological agents within 24 weeks prior to enrollment; 14. Used any prescription drugs, over-the-counter drugs, Chinese herbs and functional vitamins within 2 weeks before enrollment; 15. Those who were vaccinated within 4 weeks prior to enrolling, or who planned to be vaccinated during the trial; 16. Patients who are pregnant or lactating, or who test positive for blood pregnancy; 17. Patients who donated blood, including component blood or substantial blood loss (>=400mL), or received blood transfusions or used blood products within 12 weeks prior to screening; 18. Fever (body temperature >37.6°C) developed during the first 2 weeks of enrollment, such as fever associated with symptomatic viral or bacterial infection; 19. Enrolled in any clinical trials within 12 weeks prior to enrollment; 20. Those who cannot accept uniform diet and have special requirements for diet; 21. Long term work in dust environment before screening; 22. Other conditions deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;STAT6 phosphorylation levels in peripheral blood mononuclear cells;Blood anti-drug antibodies and neutralizing antibodies;Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram;Physical examination; | — |
Countries
China
Contacts
Public ContactZhao Hui, Hu Wei
Drug Clinical Trial Research Center, the Second Hospital of Anhui Medical University
Outcome results
None listed