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

NCT07637981 | Recruiting Phase 2 DMC

• 2 other identifiers: DX243-1012023-505778-14-00
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-related Hearing Loss

Keywords

Age-related hearing loss; DX243

Outcome Measures

Primary Outcomes (4)

• Safety and tolerability: incidence, nature, severity and causality of treatment emergent adverse events (TEAE) and (Serious) Adverse events (S)(AEs)

  Through study completion, an average 7 months

• Tolerability at the injection sites using a 1-5 scale Common Terminology Criteria for Adverse Events (CTCAE) for pain, erythema, swelling, induration, nodule and ulceration with 1 : normal and 5: worst possible symptom/sign

  For 14 days or up to normalisation after each administration whichever comes first

• Number of participants with at least one clinically significant abnormal laboratory result

  Prespecified hematology, coagulation, and clinical chemistry laboratory tests will be measured in standard local laboratory units throughout the study. Each analyte will be assessed individually against the applicable reference range and for clinical significance. For this outcome measure, a patient will be counted once if he/she has at least one post-baseline abnormal clinically relevant laboratory value.

  For 7 months

• Number of Participants With Abnormal ECG Findings

  Twelve-lead triplicate ECGs will be obtained at each scheduled assessment throughout the study. PR interval, QRS duration, QT interval, and QTcF interval will be measured on each of the three ECG tracings. Overall ECG interpretation (normal/abnormal) and clinical significance of any abnormality will be determined by the investigator or qualified reader based on review of the triplicate ECG assessment. For this outcome measure, a participant will be counted once if at least one post-baseline ECG assessment is abnormal.

  For 7 months

Secondary Outcomes (6)

• Change in Pure Tone Audiometry

  For 7 months

• Change in speech audiometry

  For 7 months

• Hearing Handicap Inventory for the Elderly- Screening (HHIE-S) questionnaire score

  For 7 months

• Severity of tinnitus

  For 7 months

• Distorsion Product OtoAcoustic Emission (DPOAE)

  For 7 months

Study Arms (3)

DX243 low flat dose

EXPERIMENTAL

Flat dose administered sub-cutaneously for 1 month

Drug: DX243

DX243 high flat dose

EXPERIMENTAL

Flat dose administered sub-cutaneously for 1 month

Drug: DX243

Placebo

PLACEBO COMPARATOR

Placebo administered sub-cutaneously for 1 month

Drug: Placebo

Interventions

Placebo DRUG

Placebo solution, matching the external appearance of DX243.

Placebo

DX243 DRUG

DX243 10 mg/mL

DX243 high flat dose; DX243 low flat dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dendrogenix: lead

Study Sites (1)

Centre hospitalier Universitaire de Liège Sart Tilman

Liège, Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: June 10, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)