[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494005":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":30,"locations":41,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":30,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Arcturus Therapeutics, Inc.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"ARCT-032, Healthy Adults","EXPERIMENTAL","Ascending single doses of ARCT-032 administered to healthy adults via nebulizer",[13],"Drug: ARCT-032",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo, Healthy Adults","PLACEBO_COMPARATOR","Single doses of 0.9% Saline administered to healthy adults via nebulizer",[19],"Other: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"ARCT-032,. Adults with Cystic Fibrosis","Two doses of ARCT-032 administered to adults with Cystic Fibrosis via nebulizer",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","ARCT-032","ARCT-032 is messenger RNA (mRNA) coding for cystic fibrosis transmembrane conductance regulator (CFTR) protein, formulated in a lipid nanoparticle (LNP).",[9,21],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"OTHER","Placebo","Normal saline",[15],[37],{"name":38,"affiliation":39,"role":40},"Clinical Program Director","Arcturus Therapeutics","STUDY_DIRECTOR",[42],{"facility":43,"status":30,"city":44,"state":30,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":30},"New Zealand Clinical Research","Christchurch","8011","New Zealand","NZ",{"type":49,"coordinates":50},"Point",[51,52],172.63333,-43.53333,{"lat":52,"lon":51},{"type":55,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[57],{"name":58,"class":59},"Novotech CRO","UNKNOWN","100494005","phase-1-safety-tolerability-and-pharmacokinetics-of-arct-032-in-healthy-adult-subjects-and-adults-with-cystic-fibrosis-100494005",false,"NCT05712538","Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.","A Study in Two Parts: (Phase 1) A Randomized, Double-blinded, Placebo--controlled, Single-ascending-dose Study in Healthy Adult Subjects and (Phase 1b) an Open-label, Nested, Divided-dose Study in Adults With Cystic Fibrosis to Assess the Safety, Tolerability, and Pharmacokinetics of ARCT-032","Key Inclusion Criteria:\n\n1. Phase 1: Healthy males or females aged 18 to 65 years at the time of informed consent.\n\n   Phase 1b: Males or females aged 18 to 65 years with confirmed diagnosis of CF documented in subject's medical record\n2. Body weight between 40-100Kg and body mass index between 16-35 kg\u002Fm2\n3. Phase 1: Forced expiratory volume (FEV1) at screening \\>85% of predicted value for age, sex, and height.\n\n   Phase 1b: FEV1 at screening between 50% and 100% of predicted value\n4. Surgically sterile or using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of study drug.\n5. Phase 1b only: Subjects with CF on CFTR modulator therapy must be on a stable regimen for at least 2 months prior to screening.\n\nKey Exclusion Criteria:\n\n1. History of illness or condition that might pose an additional risk or may confound study results.\n2. Pregnant or lactating (breast feeding)\n3. History of severe allergic reaction to a liposomal product\n4. Clinically significant abnormalities in Screening laboratory results\n5. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B\n6. Treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longer\n7. Drug or alcohol abuse within the past year\n8. History of moderate to heavy smoking or vaping (\\>10 cigarettes\u002Fsessions per day) within 6 months prior to the dose of study drug. Participants must be willing to refrain from smoking or vaping within 1 week of dosing through Day 15\n9. Systemic or inhaled corticosteroids within 3 months prior to screening (Phase 1 only).\n10. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study",true,"ALL","18 Years","65 Years",{"count":72,"type":73},39,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects (Phase 1) and of two doses in Adults with Cystic Fibrosis (Phase 1b).",[79],"Cystic Fibrosis",[81],"Cystic Fibrosis, CF","COMPLETED","2024-11-11",{"date":85,"type":73},"2024-11-13",{"date":87,"type":73},"2023-02-15",{"date":89,"type":73},"2024-07-29",{"name":5,"class":6},1]