RecruitingPhase 2NCT07418736

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

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)


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

318 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests CM326, an investigational drug, in people with moderate to severe COPD (chronic obstructive pulmonary disease — a lung condition that makes breathing difficult). The goal is to see if CM326 is safe and can improve lung function and reduce flare-ups. **You may be eligible if...** - You are 40 to 85 years old and weigh at least 40 kg - You have been diagnosed with COPD for at least 12 months - Your lung function tests confirm moderate-to-severe COPD (specific spirometry criteria) - You have been on stable COPD medication for at least 3 months **You may NOT be eligible if...** - You have a recent COPD exacerbation or serious infection - You have other significant lung or heart conditions - You are outside the age or weight range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCM326 dose 1

subcutaneous injection

DRUGCM326 dose 2

subcutaneous injection

OTHERPlacebo

subcutaneous injection


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT07418736


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