Phase II Study to Test CM326 Monoclonal Antibody Injection for Treating Moderate to Severe Chronic Obstructive Pulmonary Disease in Adults Aged 40 to 85

What this Trial Is About

Researchers are evaluating CM326, a recombinant humanized monoclonal antibody, in people with moderate to severe Chronic Obstructive Pulmonary Disease COPD. This Phase II, multi-center, randomized, double-blind, placebo-controlled study aims to assess the medicines effectiveness, safety, how the body processes it, its biological effects, and immune response in adults aged 40 to 85 years with a COPD diagnosis lasting at least one year. The study is sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Participants will be randomly assigned to receive one of two doses of CM326 or a placebo, each given by subcutaneous injection. The study includes a screening period of up to four weeks, followed by a 24 to 52-week treatment phase, and then a 12-week safety follow-up period. During the trial, participants will continue their stable background COPD therapy and are required to use highly effective contraception if applicable. Throughout the study, participants will undergo assessments including lung function tests like forced expiratory volume FEV1, forced vital capacity FVC, and forced expiratory flow FEF, as well as questionnaires measuring respiratory symptoms and quality of life. Researchers will monitor the rate and timing of COPD exacerbations, changes in blood markers, immune responses, and any adverse events. The total participation time may last up to approximately 68 weeks, including all study phases.

A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease