Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects and COPD Patients

Korábbi kezelés

• Accept experimental drugs or use experimental medical devices within 1 months or less than 5 times the half-life of the drug, whichever is longer;
• Previously known infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) liver or hepatitis C virus (HCV); or randomized pre-HIV (according to the test center SOP), treponema pallidum antibody (TPPA), HBV surface antigen or HCV antibody positive;
• There is a history of smoking and alcoholism in the 3 months before screening: smoking (more than 5 cigarettes or equivalent tobacco per day); alcoholism (more than 14 units of alcohol per week: 1 unit = 360 mL of beer, or 25 mL of spirits with a concentration of 40% or more, or 1 glass of wine, 180mL);
• Before randomization, positive for alcohol or drug abuse or nicotine in urine;
• During the study, there is a surgical plan or may interfere with the treatment plan carried out by the study;
• Prescription was used within 14 days before the first administration or within 48 hours before the first administration;
• Drugs that have used strong/intermediate inhibitors or induce liver drug metabolic enzyme CYP3A4 14 days before the first administration or ingest grapefruit or related products within 7 days before the first administration;

Más betegség

• Healthy subjects: in the past 12 weeks, antibiotics have been used for upper and lower respiratory tract infections, or have a history of respiratory infections within the past 4 weeks; COPD patients: in the past 4 weeks, antibiotics have been used for lower respiratory tract infections;
• Any organ system has a history of malignant tumors;
• Known to be allergic to any accessories in the research drug or formulation;
• In the past five years, there has been a history of drug abuse and drug dependence;
• During the study, it was expected to use drugs that had an effect on P-gp or breast cancer drug-resistant protein (BCRP).

Laborértékek

• Healthy subjects: abnormal laboratory or physical examination results of clinical significance;

Egyéb

• The average value of QTcF for 3 times at screening is ≥450ms;
• In the past four weeks, there have been blood donations or large blood loss (more than 400 milliliters), or those who intentionally donate blood during the study;
• In the past, there were difficulties in collecting blood or could not withstand intravenous puncture, such as needle halo and blood halo
• Inability or unwillingness to fully comply with the research program;
• Mentally or legally incapacitated;
• The researchers believe that there are any other reasons why the subjects are unfit to participate in the study;

• Sign an informed consent forms；
• Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); COPD patients aged 40-75 (both ends, subject to the signing of the informed consent form);
• Weight ≥45 kg，BMI 18-33 kg/m2 (include 33 kg/m2);
• During the screening period, the vital signs of healthy subjects are normal:
  • Shrinkage 90-140 mmHg,
  • diastolic pressure 50-90 mmHg,
  • Heart rate 40-100 times/min;
• During the screening period, the lung function of healthy subjects is normal, that is, the predicted value of FEV1≥80% and the predicted value of FEV1/FVC≥92%; After COPD patients inhale bronchodilators, he predicted value of FEV1≥40% and the predicted value of FEV1/FVC<0.7;
• During screening, the 12-lead ECG is normal or abnormal but has no clinical significance.
• Follow the contraceptive requirements within 14 weeks from the beginning of the consent to the last dose, and do not donate sperm during the consent period;
• During the study, all research regulations and procedures can be followed, and the atomization devices used by the research institute can be used correctly;
• Healthy subjects: non-smoking or quitting smoking ≥ 12 months, the previous smoking history < 5 packs of years; COPD patients: the previous smoking history ≥ 10 packs of years.