[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593829":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL",null,[13],"Biological: CM512 injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Group 2","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BIOLOGICAL","CM512 injection","subcutaneous injection",[9],{"type":26,"name":27,"description":23,"armGroupLabels":28,"otherNames":11},"DRUG","Placebo",[15],[30],{"name":31,"affiliation":32,"role":33},"Ruchong Chen","The First Clinical Hospital of Guangzhou Medical University","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[41],{"facility":32,"status":42,"city":43,"state":44,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Guangzhou","Guangdong","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54],{"name":31,"role":37,"phone":55,"phoneExt":11,"email":56},"13710723826","chen_rch@163.com",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100593829","phase-2-study-of-cm512-injection-in-subjects-with-moderate-to-severe-asthma-100593829",false,"NCT07011524","Study of CM512 Injection in Subjects With Moderate-to-severe Asthma","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Moderate-to-severe Asthma.","Inclusion Criteria:\n\n* Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.\n* Age ≥ 18 years old and ≤ 75 years old.\n* Body mass index (BMI) ≥ 18.0 kg\u002F(m\\*m).\n* Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months with a stable dose ≥1 month prior to Visit 1.\n* Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.\n* Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5\n\nExclusion Criteria:\n\n* Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.\n* With a history of drug abuse within the past 5 years before screening visit.\n* Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.\n* With any medical or non-medical conditions that are not suitable for participation in this study by investigators.","ALL","18 Years","75 Years",{"count":70,"type":71},200,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with moderate-to-severe asthma.",[77],"Asthma","2025-08-21",{"date":80,"type":81},"2025-08-28","ACTUAL",{"date":83,"type":81},"2025-08-19",{"date":85,"type":71},"2027-07-21",{"name":5,"class":6},1]