A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Aerosol Inhaler Administered in Healthy Subjects and Multiple Doses in Patients With COPD
The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalationadministered in a single dose in healthy individuals and multiple doses in patients with COPD。
• Informed consent was obtained to participate in the trial
• Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included)
• The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
• 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
• 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:
• Vital signs were normal at screening
• Pulmonary function was normal during screening
• No smoking or smoking cessation ≥12 months before screening, and previous smoking history \<5 pack-years;
• Healthy male 18-50 years old The following inclusion criteria apply only to subjects with COPD
⁃ Male or female, aged 40-75 years;
⁃ Patients diagnosed with COPD;
⁃ A post-bronchodilator FEV1 /FVC \< 0.7,40% ≤FEV1 \< 80% of the predicted value,;
⁃ Smoking history of≥ 10 pack-years;
⁃ Normal chest X-ray examination results at screening;
⁃ Supporting discontinuation of COPD-related medications before randomization;