[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prana Therapies Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100611806",false,"NCT07245368","Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma","A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma","Phase 1\n\nInclusion Criteria:\n\n* Age 18-65\n* Must be in good health with no significant medical history\n* Willing and able to attend all study visits, comply with study requirements\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence of clinically significant condition or disease\n* Any physical or psychological condition that prohibits study completion\n* Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and\u002For smoking or nicotine-containing product use within 3 months prior to the first dose of study agent\n* History of severe allergic reactions or hypersensitivity\n* Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing\n\nPhase 2a\n\nInclusion criteria:\n\n* Age 18-65\n* Must be in good health with no significant medical history\n* Willing and able to attend all study visits, comply with study requirements.\n* Able and willing to provide written informed consent\n* Documented asthma diagnosis prior for at least 12 months prior to screening.\n* Symptomatic asthma\n* Currently receiving maintenance asthma medications\n\nExclusion Criteria:\n\n* Evidence of clinically significant condition or disease\n* Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and\u002For smoking or nicotine-containing product use within 3 months prior to the first dose of study agent\n* Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing\n* History of severe allergic reactions or hypersensitivity\n* Current or former smoker with a smoking history of ≥10 pack-years\n* Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening\n* Other investigational agent(s) within 30 days of dosing",true,"ALL","18 Years","65 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Phase 1 of this study will consist of 2 parts\n\n* Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC).\n* Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously.\n\nPhase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase was determined from Phase 1.",[28],"Mild to Moderate Asthma",[30,31,32,33,34],"healthy volunteers","pharmacodynamics","immunogenicity","asthma","pharmacokinetics","RECRUITING","2026-03-18",{"date":38,"type":39},"2026-03-20","ACTUAL",{"date":41,"type":39},"2025-11-04",{"date":43,"type":21},"2027-01-31",{"name":45,"class":46},"Prana Therapies Inc","INDUSTRY",7,""]