[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611806":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":42,"centralContacts":47,"locations":53,"responsibleParty":163,"collaborators":42,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":42,"eligibilityCriteria":171,"healthyVolunteers":172,"sex":173,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":42,"studyType":179,"phases":180,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":56,"whyStopped":42,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Prana Therapies Inc","INDUSTRY",[8,14,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1, Part 1: SAD Cohorts: Active Drug","EXPERIMENTAL","Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format.",[13],"Drug: PRA-216",{"label":15,"type":16,"description":17,"interventionNames":18},"Phase 1, Part 1: SAD Cohorts: Placebo","PLACEBO_COMPARATOR","Healthy volunteers will receive a single dose of placebo",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 1, Part 2: MAD Cohort: Active Drug","Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Phase 1, Part 2 MAD Cohort: Placebo Comparator","Healthy volunteers will receive repeated doses of placebo comparator.",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"Phase 2a: Participants with mild to moderate asthma-active drug","Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216.",[13],{"label":33,"type":16,"description":34,"interventionNames":35},"Phase 2a: Participants with mild to moderate asthma-placebo","Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo.",[19],[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","PRA-216","biologic",[9,21,29],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Placebo","matching placebo for PRA-216",[15,25,33],[48],{"name":49,"role":50,"phone":51,"phoneExt":42,"email":52},"Linear site contact","CONTACT","+61 (0)8 6382 5110","enquiries@linear.org.au",[54,73,88,103,116,128,140,155],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Emertitus Research Sydney","RECRUITING","Botany","New South Wales","2019","Australia","AU",{"type":63,"coordinates":64},"Point",[65,66],151.19591,-33.94599,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":71,"phoneExt":42,"email":72},"Ronald Mak, 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Bardin","0395942279","philip.bardin@monashhealth.org",{"facility":104,"status":56,"city":105,"state":106,"zip":107,"country":60,"countryCode":61,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Linear","Joondalup","Western Australia","6027",{"type":63,"coordinates":109},[110,111],115.76835,-31.74445,{"lat":111,"lon":110},[114],{"name":42,"role":50,"phone":115,"phoneExt":42,"email":52},"011 61 88 6382 5110",{"facility":104,"status":56,"city":117,"state":106,"zip":118,"country":60,"countryCode":61,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Nedlands","6009",{"type":63,"coordinates":120},[121,122],115.8073,-31.98184,{"lat":122,"lon":121},[125],{"name":126,"role":50,"phone":127,"phoneExt":42,"email":52},"site contact","08 6382 5110",{"facility":129,"status":56,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":42,"geoPoint":42,"contacts":135},"PCRN Waikato, Nawton","Hamilton","Auckland","3200","New 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9201800","clinicaltrials@uhhc.co.nz",{"type":164,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100611806","phase-1-study-of-pra-216-in-healthy-participants-and-participants-with-mild-to-moderate-asthma-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":177,"type":178},96,"ESTIMATED","INTERVENTIONAL",[181,182],"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.",[185],"Mild to Moderate Asthma",[187,188,189,190,191],"healthy volunteers","pharmacodynamics","immunogenicity","asthma","pharmacokinetics","2026-08-05",{"date":194,"type":195},"2026-08-06","ACTUAL",{"date":197,"type":195},"2025-11-04",{"date":199,"type":178},"2027-01-31",{"name":5,"class":6},8]