A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Launched by KEYMED BIOSCIENCES CO.LTD · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM512 for adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it hard to breathe. The trial aims to see if CM512 is safe and effective for people who have been diagnosed with COPD for at least a year and are currently using inhalers. To be eligible, participants need to be between 40 and 80 years old, have had at least two moderate or one severe flare-up of their COPD in the past year, and have a specific level of lung function.

If you or someone you know is interested in participating, you should be aware that the study is not recruiting yet. Participants will receive either the CM512 treatment or a placebo (a harmless substance with no active medicine) and will be closely monitored throughout the study. It’s important that participants do not have other serious lung diseases, are not currently pregnant or breastfeeding, and do not have unstable health conditions that could interfere with the study. This trial may help find new ways to improve treatment for COPD, which could benefit many people living with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 40 to ≤ 80 years old
• • BMI ≥ 18.0 kg/(m\*m)
• • COPD diagnosis≥1 year
• • Post-BD FEV1 ≥ 30% and \< 80%, FEV1/FVC \<0.70 at screening
• • Triple (LABA+LAMA+ICS) or dual inhaled (LABA+LAMA or LABA+ICS) COPD therapy ≥3 months prior to V1
• • 2 moderate or ≥1 severe COPD exacerbations in the prior year
• • CAT ≥10 at screening
• • Former or current smokers ≥10 pack-years
• Exclusion Criteria:
• • Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
• • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
• • Treatment with oxygen of more than 15 hours per day.
• • Pregnant or breastfeeding.
• • The chest/lungs with pathology that precludes the patient's ability to complete the study.