[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591416":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":36,"locations":11,"responsibleParty":42,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":11},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose 1","EXPERIMENTAL",null,[13],"Biological: CM512",{"label":15,"type":10,"description":11,"interventionNames":16},"Dose 2",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR",[21],"Drug: Placebo",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"BIOLOGICAL","CM512","Administered SC",[9,15],{"type":29,"name":18,"description":26,"armGroupLabels":30,"otherNames":11},"DRUG",[18],[32],{"name":33,"affiliation":34,"role":35},"Jinfu Xu","Huadong Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",{"type":43,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100591416","phase-2-a-study-of-cm512-in-subjects-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-100591416",false,"NCT06980142","A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating CM512 Injection in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* 40 to ≤ 80 years old\n\n  * BMI ≥ 18.0 kg\u002F(m\\*m)\n  * COPD diagnosis≥1 year\n  * Post-BD FEV1 ≥ 30% and \\\u003C 80%, FEV1\u002FFVC \\\u003C0.70 at screening\n  * Triple (LABA+LAMA+ICS) or dual inhaled (LABA+LAMA or LABA+ICS) COPD therapy ≥3 months prior to V1\n* 2 moderate or ≥1 severe COPD exacerbations in the prior year\n\n  * CAT ≥10 at screening\n  * Former or current smokers ≥10 pack-years\n\nExclusion Criteria:\n\n* Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).\n* 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.\n* Treatment with oxygen of more than 15 hours per day.\n* Pregnant or breastfeeding.\n* The chest\u002Flungs with pathology that precludes the patient's ability to complete the study.","ALL","40 Years","80 Years",{"count":55,"type":56},204,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Explore the Efficacy and Safety of CM512 Injection in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)",[62],"Chronic Obstructive Pulmonary Disease","NOT_YET_RECRUITING","2025-05-12",{"date":66,"type":67},"2025-05-20","ACTUAL",{"date":69,"type":56},"2025-06-20",{"date":71,"type":56},"2028-03-17",{"name":5,"class":6}]