a clinical trial of tqc3721 suspension for inhalation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to evaluate the safety, tolerability and pharmacokinetic characteristics of tqc3721 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy tqc3721 suspension for inhalation in multiple administrations in patients with chronic obstructive pulmonary disease（copd）and asthma.


Eligibility criteria:
inclusion criteria: * sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the test; * able to complete the study according to the requirements of protocol; * aged between 18 and 65 years old, both men and women; * for healthy subjects: male ≥50kg, female ≥45kg,body mass index(bmi)=weight (kg)/height 2 (m2), bmi is 18-28 kg/m2 (including the critical value); for patients: bmi is 18-28 kg/m2 (including the critical value), and body weight is ≥45kg. * for healthy subjects: normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance; * for healthy subjects: fev1 and forced vital capacity(fvc) are at least 90% of the predicted values; * subjects (including male subjects) have no pregnancy plan and have voluntarily taken effective contraceptive measures for at least 1 month after being screened to the last use of the study drug; * for patients: vital signs range: systolic blood pressure 90 to 140mmhg, diastolic blood pressure 50 to 90 mmhg, heart rate 50 to 90 bpm; * for patients: 12-lead electrocardiogram with qt interval corrected ≤450 msec (males) or ≤470 msec (females), qrs interval ≤120 msec, pr interval ≤200 msec and no morphologic and other clinical significant abnormalities (such as left band branch block, atrioventricular node dysfunction, ischemic st segment abnormalities); * for patients: ability to perform acceptable and reproducible spirometry; * for patients: according to the diagnostic criteria of 2018 practical edition of guidelines for the diagnosis and treatment of copd, the patient was diagnosed with copd for at least 1 year;post-bronchodilator spirometry at screening must demonstrate fev1/fvc ratio of ≤0.70 and fev1 must be ≥40 % to ≤80% of predicted normal; * for patients: mmrc scoring at screening ≥2; * for patients: clinically stable copd in the previous 4 weeks; * for patients: capable of withdrawing long acting bronchodilators until the end of the treatment period, and short acting bronchodilators for 8 hours prior to administration of study medication; * for patients: current and former smokers with a smoking history of ≥10 pack years（smoking at least 20 cigarettes a day for 10 years or at least 10 cigarettes a day for 20 years）; * for patients: beta agonists are currently used only "when needed"; * for patients: never smoked or an ex-smoker for ≥6 months； exclusion criteria: * preexisting or existing the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, immune system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator assesses that may affect drug metabolism or safety. * for healthy subjects: have a history of fainting needles, fainting blood. * for healthy subjects: known allergy to the study drug and their metabolites or any of the excipients of the formulation. * for healthy subjects: those who smoked more than 5 cigarettes per day during the 3 months before the trial. * a history of alcohol abuse in the past 6 months (14 units of alcohol consumed per week: 1 unit =360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine). * for healthy subjects: donated blood or had substantial loss of blood (more than 400 ml) within 2 months before the test. * for healthy subjects: had taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug. * participated in other clinical trials within 3 months prior to this study. * positive for hepatitis (including hepatitis b and c), human immunodeficiency virus（hiv） or syphilis at screening. * women who are pregnant or breast-feeding. * positive test for alcohol. * for healthy subjects: blood collection is difficult or cannot tolerate venipuncture blood collection. * for healthy subjects: the subject is unable or can not comply with ward management regulations. * for healthy subjects: the subject is unable to complete the study due to personal reasons. * for healthy subjects: any circumstances that the investigator considers to pose a safety risk to the subject during the study or may interfere with the conduct of the study. * for patients: intolerance to salbutamol, tiotropium, or this product or prior exposure to ensifentrine (rpl554). * for patients: use of any medicine within 4 weeks prior to initiation of the study drug, including non-prescription medications and herbs, except vitamins. * for patients: physical examination findings that researchers consider clinically significant at the time of screening. * for patients: a history of cardiovascular disease (including arrhythmias) or active hyperthyroidism. * for patients: history of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin.