A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM326 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease（COPD）
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease. The study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.
• Understand the study and voluntarily sign the informed consent form.
• Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
• weight ≥40 kg.
• Diagnosed with COPD for at least 12 months.
• Post-bronchodilator FEV1/FVC ratio \<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \<80%.
• Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening.
• Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening.
• COPD assessment test (CAT) Total Score ≥10.
• Blood eosinophils ≥0.15×10\^9 /L at screening.
⁃ Current smoking or a history of smoking ≥ 10 pack-years, or exposure to biomass smoke (including but not limited to biomass fuel, secondhand smoke, and the like) for ≥ 10 years.
⁃ Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.