COPD
Conditions
Brief summary
The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension administered in a single dose in healthy individuals and multiple doses in patients with COPD
Interventions
DRUGHRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension
HRS-9821 Powder for Inhalation. HRS-9821 inhalation suspension
DRUGHRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo
HRS-9821 Powder for Inhalation placebo. HRS-9821 inhalation suspension placebo
Moxifloxacin Hydrochloride Tablets
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Informed consent was obtained to participate in the trial 2. Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included) 3. The 12-lead ECG was normal or abnormal but clinically insignificant until randomization 4. Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821/ placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose 5. All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study The following inclusion criteria apply only to healthy subjects: 6. Vital signs were normal at screening 7. Pulmonary function was normal during screening 8. No smoking or smoking cessation ≥12 months before screening, and previous smoking history \<5 pack-years； 9. Healthy male 18-50 years old The following inclusion criteria apply only to subjects with COPD 10. Male or female, aged 40-75 years; 11. Patients diagnosed with COPD; 12. A post-bronchodilator FEV1 /FVC \< 0.7,40% ≤FEV1 \< 80% of the predicted value,; 13. Smoking history of≥ 10 pack-years; 14. Normal chest X-ray examination results at screening; 15. Supporting discontinuation of COPD-related medications before randomization；
Exclusion criteria
1. Mean QTcF ≥ 450 ms at screening； 2. Persons who had donated blood or had massive blood loss (\> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study 3. Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater; 4. Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood 5. History of malignancy in any organ system 6. Known allergies to salbutamol, study medication, or any excipients in the formulation 7. Known previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); Or positive HIV (according to a trial-site SOP), treponema pallidum antibody, HBV surface antigen, or HCV antibody before randomization 8. History of alcohol abuse 9. History of drug abuse and drug dependence in the past 5 years； 10. Positive for alcohol or substance abuse test before randomization 11. During the study, surgery or treatment that might interfere with the conduct of the study was planned； 12. Unable or unwilling to fully adhere to the study protocol 13. Mentally or legally incapacitated 14. There were any other reasons for the subject not to participate in the study in the opinion of the investigator; 15. Use of a strong/moderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose; 16. Drugs with effects on P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) were anticipated to be used during the study; 17. History of using HRS-9821 suspension; The following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the rate of adverse events | The screening period lasted until 40 days after administration |
Secondary
| Measure | Time frame |
|---|---|
| Changes in QT interval from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects. | The screening period lasted until 29 days after administration |
| Lung epithelial lining fluid (ELF) drug concentrations based on alveolar lavage (BAL) measurements in healthy subjects after a single dose of HRS-9821 aerosol inhalation | The screening period lasted until 29 days after administration |
| Theoretical intracellular drug concentrations based on alveolar lavage fluid (BALF) cells measured by alveolar lavage (BAL) after a single dose of HRS-9821 aerosol inhalation in healthy subjects. | The screening period lasted until 29 days after administration |
| Plasma drug concentration after administration | The screening period lasted until 40 days after administration |
| Changes in heart rate from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects。 | The screening period lasted until 29 days after administration |
Countries
China
Contacts
CONTACTHuanhuan Huang
Outcome results
None listed