A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of the Efficacy and Safety of Inhaled TQC3721 Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)

Inclusion Criteria:

• Sign informed consent before the test and fully understand the test content, process and possible adverse reactions.
• Male and female subjects aged 40 to 80 years old (including the cut-off value).
• Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)
• Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug.
• Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria.
• Able to conduct acceptable and reproducible lung function tests.
• COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
• Smoking history ≥ 10 pack years.

Exclusion Criteria:

• History of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
• Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit.
• Screening for hospitalization history due to COPD within the first 6 months.
• Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit.
• Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD.
• Previous lung resection or lung reduction surgery.
• Pulmonary rehabilitation treatment.
• Previously received TQC3721 treatment.
• Patients who received immunotherapy within the first 4 weeks of the screening period.
• The patient has a history of diseases that are currently beyond their control.
• History or current evidence of cardiovascular disease with clinical significance.
• History of cured or untreated malignant tumors in any organ or system within the past 5 years.
• Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit.
• Those who require oxygen therapy or intermittent oxygen therapy.
• Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study.
• Planned vaccine recipients during the period.
• Individuals who have participated in any drug or medical device clinical trials prior to screening.
• Researchers believe that there are other situations that are not suitable for participation in the study.