[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609843":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":69,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":53,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Alixer Nexgen Therapeutics Limited","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"ALDP001 0.125% w\u002Fv","EXPERIMENTAL","Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days",[13],"Drug: ALDP001 Nasal Spray",{"label":15,"type":10,"description":11,"interventionNames":16},"ALDP001 (0.25% w\u002Fv)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"ALDP001 (0.5% w\u002Fv) Nasal Spray",[13],{"label":21,"type":22,"description":11,"interventionNames":23},"Placebo Nasal Spray","PLACEBO_COMPARATOR",[24],"Drug: Placebo Nasal spray",[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","ALDP001 Nasal Spray","Experimental Arm",[15,18,9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo Nasal spray","Controlled arm",[21],[37],{"name":38,"affiliation":39,"role":40},"Patricia Couroux, MD","Cliantha Research","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Akhilesh Sharma","CONTACT","+912239829999","akhilesh.sharma@alkem.com",{"name":48,"role":44,"phone":49,"phoneExt":31,"email":50},"Yogesh Rane","+919820587254","yogesh.rane@alkem.com",[52],{"facility":39,"status":53,"city":54,"state":55,"zip":31,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Mississauga","Ontario","Canada","CA",{"type":59,"coordinates":60},"Point",[61,62],-79.6583,43.5789,{"lat":62,"lon":61},[65,68],{"name":38,"role":44,"phone":66,"phoneExt":31,"email":67},"(905) 282-1808","pcouroux@cliantha.com",{"name":38,"role":40,"phone":31,"phoneExt":31,"email":31},{"type":70,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100609843","phase-2-a-study-to-determine-the-optimal-dose-and-frequency-of-aldp001-nasal-spray-in-adults-with-seasonal-allergic-rhinitis-under-allergen-exposure-100609843",false,"NCT07219849","A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure","A Two-part Adaptive Double-blind Randomized Placebo-controlled Study to Assess the Appropriate Dose and the Appropriate Dosing Frequency of ALDP 001 in Adults With Seasonal Allergic Rhinitis (SAR) Assessed Using an Allergen Challenge Chamber\u002FEEC","ALDP001","Inclusion Criteria:\n\n* Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities\n* Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control) in the previous 12 months\n* Healthy as determined by a responsible and experienced Investigator, based on a medical evaluation including medical history, physical examination, vital signs, ECG, and lab tests.\n\nExclusion Criteria:\n\n* Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, sinusitis and other nasal malformations.\n* History of frequent nosebleeds.\n* Participants with rhinitis medicamentosa.\n* Current or chronic history of hepatic disease.\n* A QTcF (Fridericia-corrected QT interval) \\>450 ms in males or \\>470 ms in females.",true,"ALL","18 Years","65 Years",{"count":84,"type":85},164,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation.",[91],"Seasonal Allergic Rhinitis (SAR)",[28],"2025-10-21",{"date":95,"type":96},"2025-10-22","ACTUAL",{"date":98,"type":96},"2025-10-17",{"date":100,"type":85},"2026-04",{"name":5,"class":6},1]