A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
Trial Parameters
Brief Summary
This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.
Eligibility Criteria
Inclusion Criteria: * Age: 40-75 years old, male or female; * During screening, according to the Global Oceanographic Library for Discovery (GOLD)guidelines (2024), patients diagnosed with stable moderate to severe COPD should have Force Expiratory Volume in 1 second (FEV1)/ forced vital capacity (FVC)\<0.7 after inhaling bronchodilators; 40% ≤ FEV1 accounts for ≤ 80% of the expected value; * When screening, after inhaling salbutamol aerosol for 4 times, there is a certain reversibility in the airway: the absolute value of FEV1 improves by more than 100ml; * Being able to adjust the current COPD treatment or for COPD patients with initial treatment, prescribed bronchodilators, including Long-acting Muscarinic Antagonists (LAMA) and/or Long-acting β2-agonist (LABA) inhaled drugs, can be discontinued during the screening period after signing the informed consent form; * The subject is able to discontinue Short acting Beta agonists (SABA) for at least 6 hours and Short acting Anticholiner