[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100335423":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":27,"responsibleParty":104,"collaborators":24,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":24,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":24,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":130,"whyStopped":24,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Ionis Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IONIS-ENaCRx","EXPERIMENTAL","Ascending single and multiple doses of IONIS-ENaCRx inhaled or nebulized.",[13],"Drug: IONIS-ENaCRx",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo comparator calculated volume to match active comparator inhaled or nebulized.",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28,40,49,58,70,80,89,98],{"facility":29,"status":24,"city":30,"state":24,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":24},"Universitätsmedizin Essen","Essen","45239","Germany","DE",{"type":35,"coordinates":36},"Point",[37,38],7.01228,51.45657,{"lat":38,"lon":37},{"facility":41,"status":24,"city":42,"state":24,"zip":43,"country":32,"countryCode":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":24},"Universitätsklinikum Frankfurt","Frankfurt","D-60589",{"type":35,"coordinates":45},[46,47],10.53333,49.68333,{"lat":47,"lon":46},{"facility":50,"status":24,"city":51,"state":24,"zip":52,"country":32,"countryCode":33,"cosmosGeoPoint":53,"geoPoint":57,"contacts":24},"Lungenheilkunde München-Pasing","München","81241",{"type":35,"coordinates":54},[55,56],13.31243,51.60698,{"lat":56,"lon":55},{"facility":59,"status":24,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":24},"Medicines Evaluation Unit","Wythenshawe","Manchester","M23 9QZ","United Kingdom","UK",{"type":35,"coordinates":66},[67,68],-2.2654,53.38027,{"lat":68,"lon":67},{"facility":71,"status":24,"city":72,"state":73,"zip":74,"country":63,"countryCode":64,"cosmosGeoPoint":75,"geoPoint":79,"contacts":24},"Celerion","Belfast","Northern Ireland","BT9 6AD",{"type":35,"coordinates":76},[77,78],-5.92541,54.59682,{"lat":78,"lon":77},{"facility":81,"status":24,"city":82,"state":24,"zip":83,"country":63,"countryCode":64,"cosmosGeoPoint":84,"geoPoint":88,"contacts":24},"Western General Hospital","Edinburgh","EH4 2XU",{"type":35,"coordinates":85},[86,87],-3.19648,55.95206,{"lat":87,"lon":86},{"facility":90,"status":24,"city":91,"state":24,"zip":92,"country":63,"countryCode":64,"cosmosGeoPoint":93,"geoPoint":97,"contacts":24},"Adults Cystic Fibrosis King's College Hospital - Hambleden Wing (East)","London","SE5 9RS",{"type":35,"coordinates":94},[95,96],-0.12574,51.50853,{"lat":96,"lon":95},{"facility":99,"status":24,"city":91,"state":24,"zip":100,"country":63,"countryCode":64,"cosmosGeoPoint":101,"geoPoint":103,"contacts":24},"Royal Brompton Hospital","SW3 6HP",{"type":35,"coordinates":102},[95,96],{"lat":96,"lon":95},{"type":105,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100335423","phase-1-a-phase-12a-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-and-multiple-doses-of-ionis-enacrx-in-healthy-volunteers-and-patients-with-cystic-fibrosis-100335423",false,"NCT03647228","A Phase 1\u002F2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis","A Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1\u002F2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION-827359, an Antisense Oligonucleotide Inhibitor of ENaC, Administered to Healthy Volunteers and Patients With Cystic Fibrosis","Inclusion Criteria (Healthy Volunteers)\n\n1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.\n2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method\n3. Willing to refrain from strenuous exercise\u002Factivity for at least 72 hours prior to study visits\n4. Body mass index (BMI) \\\u003C 35 kg\u002Fm2 with a minimum weight of 45 kg\n5. Normal diffusing capacity in the lung (≥ 80% predicted) at Screening\n\nExclusion Criteria (Healthy Volunteers)\n\n1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to:\n\n   1. Urine protein\u002Fcreatinine (P\u002FC) ratio ≥ 0.2 mg\u002Fmg\n   2. Positive test (including trace) for blood on urinalysis\n   3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, alkaline phosphatase (ALP), serum creatinine, blood urea nitrogen (BUN), fasting blood glucose, potassium \\> upper limit of normal (ULN)\n   4. Platelet count \\\u003C LLN\n2. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1\n3. Respiratory infection within 4 weeks of Study Day 1\n4. Presence or past history of CS chronic respiratory disease, including any current history (or within 2 years) of asthma. History of allergic rhinitis is acceptable\n5. Forced expiratory volume in 1 second (FEV1) \\\u003C 80% of predicted at Screening or an FEV1\u002FFVC ratio of \\\u003C 0.7\n6. Smoking of a tobacco or nicotine-containing product within the previous 6 months (use of a nicotine patch is permitted) or a smoking history of ≥ 10 pack years\n7. Any CS finding on chest radiograph\n8. Uncontrolled hypertension (blood pressure \\[BP\\] \\> 160\u002F100 mm Hg) at Screening\n9. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer\n10. Any history of previous treatment with an oligonucleotide\n11. Regular use of alcohol within 6 months prior to screening or hard drugs within 1 year prior to screening, or positive urine drug screen at Screening\n12. Blood donation of 50 to 499 mL within 30 days of screening or of \\> 499 mL within 60 days of screening\n\nInclusion Criteria (Cystic Fibrosis Participants)\n\n1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.\n2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method\n3. Confirmed diagnosis of CF by seat chloride and\u002For genetics by referring clinician\n4. FEV1 \\>\u002F= 50% of predicted\n5. Stable CF disease as judged by the Investigator\n6. Weight \\> 40 kg\n\nExclusion Criteria (Cystic Fibrosis Participants)\n\n1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to:\n\n   1. Abnormal liver function defined as \\> 2 times upper limit of normal (ULN) for bilirubin, or 3 time ULN for ALT, AST, or alkaline phosphatase\n   2. Platelet count \\\u003C LLN\n2. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1\n3. Respiratory infection within 4 weeks of Study Day 1\n4. Colonization with Burkholderia cepacia or M. abscessus",true,"ALL","18 Years","50 Years",{"count":118,"type":119},98,"ACTUAL","INTERVENTIONAL",[122],"PHASE1","This Phase 1\u002F2a study is a double-blinded (subject and Investigator), randomized, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple nebulized doses of IONIS-ENaCRx.",[125,126],"Healthy Subjects","Cystic Fibrosis",[128,129],"ION-827359","ENaC","COMPLETED","2021-02-02",{"date":133,"type":119},"2021-02-04",{"date":135,"type":119},"2018-12-13",{"date":137,"type":119},"2020-10-13",{"name":5,"class":6},8]