[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100227801":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":31,"locations":44,"responsibleParty":56,"collaborators":31,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":31,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":31,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":80,"whyStopped":81,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"JNJ-43260295 (Healthy Participants)","EXPERIMENTAL","Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils.",[13],"Drug: JNJ-43260295",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Healthy Participants)","PLACEBO_COMPARATOR","Participants will receive a single nasal dose of placebo matching to JNJ-43260295.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"JNJ-43260295 (Asthmatic Participants)","Participants will participate in 3 consecutive treatment periods (Periods 1, 2, and 3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without prior nasal allergen challenge. In Period 2, each participant will receive a single nasal dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to the dosing. In Period 3, each participant will receive single nasal allergen challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3 consecutive treatment periods.",[13,24],"Drug: Nasal Allergen Challenge",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","JNJ-43260295","A single nasal dose of JNJ-43260295, 6400 microgram, will be given.",[21,9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","A single nasal dose of placebo matching to JNJ-43260295 will be given.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Nasal Allergen Challenge","Participants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity.",[21],[41],{"name":42,"affiliation":5,"role":43},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[45],{"facility":31,"status":31,"city":46,"state":47,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":31},"Charlottesville","Virginia","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-78.47668,38.02931,{"lat":54,"lon":53},{"type":57,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100227801","phase-1-study-to-examine-the-cytokine-levels-gene-expression-and-safety-of-a-single-nasal-dose-of-jnj-43260295-in-healthy-participants-and-atopic-participants-with-mild-to-mild-persistent-asthma-100227801",false,"NCT02243189","Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma","A Phase 1 Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in a Double-Blind, Randomized, Placebo-Controlled Setting in Healthy Subjects, and by an Open-Label Assessment in Atopic Subjects With Mild to Mild-Persistent Asthma With and Without Nasal Allergen Challenge Prior to Dosing","Inclusion Criteria:\n\nA. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants:\n\n* Participants must be non-smokers or non-regular smokers (1 to 2 cigarettes on the weekend as part of social gathering) for at least 3 months prior to Screening, according to the participant's self-reported medical history. Participants should be willing to (continue to) abstain from smoking from Screening until completion of the last study related activity\n* Participants must have a body mass index (BMI: weight in kilogram \\[kg\\] divided by the height in square meter \\[m\\^2\\]) of 18.0 to 30.0 kg\u002Fm\\^2, extremes included\n* Participants must have a normal 12-lead electrocardiogram (ECG) at Screening including normal sinus rhythm (heart rate between 40 and 100 beats per minute \\[bpm\\]); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than and equal to (\\\u003C=) 450 milliseconds (ms); QRS interval lower than 120 ms; and PR interval \\\u003C=220 ms\n* Participants must be healthy, with the exception of findings related to asthma and allergy in atopic mild to mild-Persistent asthmatic participants, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs (Systolic Blood Pressure \\[BP\\], Diastolic BP, pulse rate, respiratory rate, and body temperature), and the results of blood biochemistry and hematology tests performed at Screening\n* Participants must be willing\u002F able to adhere to the prohibitions and restrictions specified in the protocol and study procedures\n\nB. Atopic Mild to Mild-Persistent Asthmatic Participants:\n\n* Participants with Investigator-diagnosed mild to mild-persistent asthma based on the Guidelines for the Diagnosis and Management of Asthma\n* Participants having a well-established allergen profile (participants have been previously skin tested and, by history, have allergic responses to specific allergens)\n* Participants with forced expiratory volume in 1 second (FEV1) greater than (\\>) 70 percent (%) of predicted at Baseline\n\nExclusion Criteria:\n\nA. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants:\n\n* Participants having a significant (by the assessment of the Investigator) nasal abnormality and\u002For has a history of nasal or sinus surgery within 12 months of enrollment\n* Participants having an upper or lower respiratory tract infection within 4 weeks of enrollment\n* Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 1 year, which in the Investigator's opinion would compromise participant's safety and\u002For compliance with the study procedures\n* Participants with a known history of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or with a known history of hepatitis A, B, or C virus infection at study Screening\n* Female participants who are breastfeeding at Screening or having a positive urine pregnancy test at Screening\n\nB. Atopic Mild to Mild-Persistent Asthmatic Participants:\n\n* Hospitalization or treatment in an emergency care facility for asthma during the last 3 years\n* Participants using nasal corticosteroids on a daily basis in the 4 weeks prior to enrollment\n* Participants who have received allergen immunotherapy in the last 2 years",true,"ALL","18 Years","55 Years",{"count":70,"type":71},17,"ACTUAL","INTERVENTIONAL",[74],"PHASE1","The purpose of this study is to investigate the cytokine levels in nasal lavage and gene expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which there is wheezing and difficulty in breathing) participants with and without nasal allergen challenge prior to dosing.",[77,78],"Healthy","Asthma",[77,78,28,37],"TERMINATED","Under enrollment and IP supply expiring.","2016-03-22",{"date":84,"type":85},"2016-03-23","ESTIMATED",{"date":87,"type":31},"2014-10",{"date":89,"type":71},"2014-12",{"name":5,"class":6},1]