RecruitingChronic Obstructive Pulmonary Disease
A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Eligible age
40–85 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
You may qualify if…
- ✓ 1. Understand the study and voluntarily sign the informed consent form.
- ✓ 2. Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
- ✓ 3. weight ≥40 kg.
- ✓ 4. Diagnosed with COPD for at least 12 months.
- ✓ 5. Post-bronchodilator FEV1/FVC ratio \<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \<80%.
- ✓ 6. Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening.
- ✓ 7. Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening.
- ✓ 8. COPD assessment test (CAT) Total Score ≥10.
You may not qualify if…
- ✕ 1. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）
- ✕ 2. Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator. Or other conditions that could lead to elevated eosinophils.
- ✕ 3. The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male \>450 msec, female \>470 msec）, or persistent arrhythmia.
- ✕ 4. History of malignancy.
- ✕ 5. Previous history of known or suspected immunosuppression; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.
- ✕ 6. Prior autoimmune disease or inflammatory treatment with biologic agents/systemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.
- ✕ 7. Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the investigator or with evidence of right cardiac failure.
- ✕ 8. Myocardial infarction, unstable angina, or stroke occurring within 6 months prior to signing the informed consent form (ICF).
Source: ClinicalTrials.gov · NCT07418736 · last updated 2026-02-18