A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD
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
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
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；
You may not be if
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;
18. Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening;
19. Abnormal laboratory or physical examination results with clinical significance;
20. Positive urine nicotine test before randomization;
21. Have consumed a prescription within 14 days prior to the first dose or over-the-counter drugs within 48 h prior to the first dose;
Clareo Health | A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD
