The increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: About a month from the first medication to the evaluation.
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 4 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 6 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 12 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 24 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 hours after the first dose
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Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 3 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 4 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 12 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 24 hours after the first dose
Evaluate the change of FEV1 peak after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: About 24 hours after the first dose
Evaluate the force lung capacity (FVC) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 hours after the first dose
Evaluate pharmacokinetics concentration and pharmacokinetic parameters of after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 weeks after the first dose