DX243: a near-term test for safety and tolerability in adults with age-related hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2a study in adults with age-related hearing loss. Sixty patients? (Note: actual N=24) will receive either two different doses of subcutaneous DX243 or placebo for 29 days, with five injections per participant. The trial aims to confirm safety and tolerability and to gather preliminary data on efficacy using tests of speech in noise, audiometry, tinnitus, and quality of life. The study follows a prior Phase 1/2a design to identify dose levels and safety profiles before broader testing. Conduct occurs at a single center in Liège, Belgium, under a lead sponsor, Dendrogenix.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre hospitalier Universitaire de Liège Sart Tilman
  Liège, Liège, Belgium Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.