About this trial
The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation administered in a single dose in healthy individuals and multiple doses in patients with COPD。
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Informed consent was obtained to participate in the trial
Body weight ≥45 kg,and 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
Disqualifiers
Mean QTcF ≥ 450 ms at screening;
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
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;
Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood
Trial design
Parallel
Treatments tested in this trial
HRS-9821 Powder for Inhalation
DrugHRS-9821 Powder for Inhalation
Placebo
Drugplacebo for HRS-9821 Powder Inhalation
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in the rate of adverse events
Secondary outcomes
Plasma drug concentration after administration
Sponsors and contacts
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