[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643036":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":29,"locations":33,"responsibleParty":53,"collaborators":29,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":29,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":36,"whyStopped":29,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Dendrogenix","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"DX243 low flat dose","EXPERIMENTAL","Flat dose administered sub-cutaneously for 1 month",[13],"Drug: DX243",{"label":15,"type":10,"description":11,"interventionNames":16},"DX243 high flat dose",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR","Placebo administered sub-cutaneously for 1 month",[22],"Drug: Placebo",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","DX243","DX243 10 mg\u002FmL",[15,9],null,{"type":25,"name":18,"description":31,"armGroupLabels":32,"otherNames":29},"Placebo solution, matching the external appearance of DX243.",[18],[34],{"facility":35,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Centre hospitalier Universitaire de Liège Sart Tilman","RECRUITING","Liège","4000","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],5.56749,50.63373,{"lat":45,"lon":44},[48],{"name":49,"role":50,"phone":51,"phoneExt":29,"email":52},"Guillaume Gersdorff, MD","CONTACT","+32 043232323","Guillaume.Gersdorff@chuliege.be",{"type":54,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100643036","phase-2-first-clinical-study-to-evaluate-safety-tolerability--pk-of-dx243-in-healthy-volunteers-and-patients-with-hearing-loss-100643036",false,"NCT07637981","First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss","Double-blind, Randomised, Placebo-controlled Phase 1\u002F2a Study of Safety, Tolerability and PK of Single and Repeated SC Doses of DX243 in Healthy Volunteers, and 1-month Safety and Efficacy in Moderately Severe Age-related Hearing Loss","DX243-101","Inclusion Criteria:\n\n* Patient having self-reported recent difficulty hearing in noisy environments for at least 6 months prior to screening.\n* Patient exhibiting a speech-in-noise hearing deficit in at least one ear;\n* Patient having audiometrically-defined normal hearing or up to moderately severe hearing impairment\n\nExclusion Criteria:\n\n* Current tympanic membrane perforation;\n* Current acute or chronic otitis;\n* Genetic hearing loss;\n* Symmetric or asymmetric severe hearing loss;\n* Any therapy known as ototoxic;\n* Acute chronic otitis media or otitis externa terminated less than 7 days prior to randomisation;\n* History of chronic inflammatory or suppurative ear disease or cholesteatoma;\n* History of otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, barotrauma;\n* Prior ear surgery of any kind;\n* Fluctuating hearing loss;\n* Patient with conductive hearing loss;\n* History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma","ALL","18 Years","75 Years",{"count":67,"type":68},24,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","Phase 2a: Multiple Ascending Dose (MAD) in male and female patients with hearing loss:\n\nThe study will be conducted according to a randomised, placebo-controlled, double-blind design. A total of 24 patients, otherwise healthy, aged up to 75 years old, with mild to moderate hearing loss will be included. Two cohorts of 12 male or female patients (no ratio is required) will receive two different flat doses (low dose and high dose) ofDX243 or placebo for 29 days using SC administration. In each cohort of 12 patients, 4 will be randomised to placebo and 8 to DX243, so at the end of Phase 2a, 8 patients will have received placebo, 8 the low dose and 8 the high dose of DX243.\n\nThe primary objective is to evaluate the safety and tolerability of DX243 administered subcutaneously after repeated doses. The secondary objectives are to detect preliminary signal of efficacy, using speech in noise tests, tonal and vocal audiometry, as well as tinnitus and quality of life.",[74],"Age-related Hearing Loss",[76,26],"Age-related hearing loss","2026-06-04",{"date":79,"type":80},"2026-06-10","ACTUAL",{"date":82,"type":80},"2026-05-13",{"date":84,"type":68},"2027-10",{"name":5,"class":6},1]