First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss
Key facts
- Where
- Liège, BelgiumSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07637981, who can take part
Where in Belgium
- Centre Hospitalier Universitaire de LiègeLiège, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Dendrogenix
- Trial code
- NCT07637981EU 2023-505778-14-00
- Record updated
- 10 June 2026
- Original description
Phase 2a: Multiple Ascending Dose (MAD) in male and female patients with hearing loss:Read full original descriptionShow less
Double-blind, Randomised, Placebo-controlled Phase 1/2a 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
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 tests, tonal and vocal audiometry, as well as tinnitus and quality of life.
Inclusion: 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: Any therapy known as ototoxic; Acute chronic otitis media or otitis externa terminated less than 7 days prior to randomisation; Prior ear surgery of any kind; Current tympanic membrane perforation; History of chronic inflammatory or suppurative ear disease or cholesteatoma; History of otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, barotrauma; History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma; Current acute or chronic otitis; Genetic hearing loss; Symmetric or asymmetric severe hearing loss; Fluctuating hearing loss; Patient with conductive hearing loss.