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
Qualifiers
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
Treatments tested in this trial
- HRS-9821 Powder for Inhalation
- Placebo