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First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss

RecruitingPhase 2Ages 18 Years - 75 YearsAllDendrogenix
NCT07637981 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Phase 2a: Multiple Ascending Dose (MAD) in male and female patients with hearing loss: The 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. The 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 tes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient having self-reported recent difficulty hearing in noisy environments for at least 6 months prior to screening. * Patient exhibiting a speech-in-noise hearing deficit in at least one ear; * Patient having audiometrically-defined normal hearing or up to moderately severe hearing impairment Exclusion Criteria: * Current tympanic membrane perforation; * Current acute or chronic otitis; * Genetic hearing loss; * Symmetric or asymmetric severe hearing loss; * Any therapy known as ototoxic; * Acute chronic otitis media or otitis externa terminated less than 7 days prior to randomisation; * History of chronic inflammatory or suppurative ear disease or cholesteatoma; * History of otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, barotrauma; * Prior ear surgery of any kind; * Fluctuating hearing loss; * Patient with conductive hearing loss; * History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma
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What it tests

  • DX243
  • Placebo
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Where

1 site
Centre hospitalier Universitaire de Liège Sart Tilman
Liège, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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