Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose Escalation of Nebulized Inhalation of HRS-9821 Suspension in Healthy Individuals and Multiple Doses in COPD Patients
The increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD patients.
• 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.