Age-related Hearing LossPhase 2DX243-101NCT07637981
First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss
A Phase 2 study testing DX243 in people with Age-related Hearing Loss, run by Dendrogenix at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Age-related Hearing Loss
- What is being tested?
- DX243
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 13 May 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Centre hospitalier Universitaire de Liège Sart Tilman
Liège, Liège, 4000
Guillaume Gersdorff, MD, +32 043232323, Guillaume.Gersdorff@chuliege.be
About this study
Official title: 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.
Read the detailed description
This is a first-in-human, randomised, double-blind, placebo-controlled Phase 1/2a study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of DX243, a novel investigational compound, in healthy volunteers and patients with mild to moderate age-related hearing loss (ARHL). The study consists of two parts: a Phase 1 segment including single and multiple ascending dose evaluations in healthy volunteers, followed by a Phase 2a extension in patients with hearing impairment. The overall design allows for dose selection and regimen optimisation based on safety and PK results obtained in earlier cohorts.
In the Phase 2a part, 24 otherwise healthy male and female patients aged up to 75 years with up to moderately severe hearing loss will be enrolled. Patients will be randomised in a double-blind manner to receive either DX243 (two dose levels) or placebo. Treatment will consist of once-weekly subcutaneous administrations over 29 days (five injections), with 2 dosing levels selected based on Phase 1 safety, PK and modelling data to achieve target plasma concentrations while minimising local tolerability issues.
The primary objective of the Phase 2a portion is to assess the safety and tolerability of repeated subcutaneous administration of DX243, including treatment-emergent adverse events, local injection site reactions, laboratory parameters, and ECG findings. Secondary and exploratory objectives include characterisation of PK parameters and evaluation of preliminary efficacy signals using a comprehensive battery of audiological tests (including speech-in-noise performance, pure tone audiometry, and auditory brainstem response), tinnitus assessments, and quality-of-life measures. Patients will be followed for up to approximately 6 months after treatment to assess longer-term safety and durability of response.
- Conditions
- Age-related Hearing Loss
- Being tested
- DX243, Placebo
- Keywords
- Age-related hearing loss, DX243
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DX243Drug
DX243 10 mg/mL
PlaceboDrug
Placebo solution, matching the external appearance of DX243.
| Study group | Role | What they receive |
|---|---|---|
| DX243 low flat dose | Experimental | Flat dose administered sub-cutaneously for 1 month Receives: Drug: DX243 |
| DX243 high flat dose | Experimental | Flat dose administered sub-cutaneously for 1 month Receives: Drug: DX243 |
| Placebo | Placebo comparator | Placebo administered sub-cutaneously for 1 month Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: incidence, nature, severity and causality of treatment emergent adverse events (TEAE) and (Serious) Adverse events (S)(AEs)
Measured: 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
Measured: 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.
Measured: 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.
Measured: For 7 months
Secondary outcomes (6)
Change in Pure Tone Audiometry
Measured: For 7 months
Change in speech audiometry
Measured: For 7 months
Hearing Handicap Inventory for the Elderly- Screening (HHIE-S) questionnaire score
0 to 8 = 13% probability of hearing impairment (no handicap/no referal) 10 to 24= 50% probability of hearing impairment (mild-moderate handicap/refer) 26 to 40=84% probability of hearing impairment (severe handicap/refer)
Measured: For 7 months
Severity of tinnitus
Tinnitus assessment (acouphenometry) and Tinnitus Functional Index (TFI)
Measured: For 7 months
Distorsion Product OtoAcoustic Emission (DPOAE)
Measured: For 7 months
Quality of Life (QoL) assessed using 15iSSQ scale
The 15-item Speech, Spatial, and Qualities of Hearing Scale is a 15-item questionnaire that evaluates hearing-related quality of life. It measures self-reported abilities in three specific hearing domains: Speech, Spatial, and Qualities of hearing. Higher scores indicate better hearing performance and fewer limitations in daily life.
Measured: For 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start13 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dendrogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637981
- Sponsor's protocol ID
- DX243-101
- Other IDs
- 2023-505778-14-00, 2023
- Acronym
- DX243-101
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07637981
- Acronym / sponsor ID
- DX243-101 / DX243-101
- Conditions
- Age-related Hearing Loss
- Keywords
- Age-related hearing loss, DX243
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- DendrogenixIndustry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human, randomised, double-blind, placebo-controlled Phase 1/2a study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of DX243, a novel investigational compound, in healthy volunteers and patients with mild to moderate age-related hearing loss (ARHL). The study consists of two parts: a Phase 1 segment including single and multiple ascending dose evaluations in healthy volunteers, followed by a Phase 2a extension in patients with hearing impairment. The overall design allows for dose selection and regimen optimisation based on safety and PK results obtained in earlier cohorts.
In the Phase 2a part, 24 otherwise healthy male and female patients aged up to 75 years with up to moderately severe hearing loss will be enrolled. Patients will be randomised in a double-blind manner to receive either DX243 (two dose levels) or placebo. Treatment will consist of once-weekly subcutaneous administrations over 29 days (five injections), with 2 dosing levels selected based on Phase 1 safety, PK and modelling data to achieve target plasma concentrations while minimising local tolerability issues.
The primary objective of the Phase 2a portion is to assess the safety and tolerability of repeated subcutaneous administration of DX243, including treatment-emergent adverse events, local injection site reactions, laboratory parameters, and ECG findings. Secondary and exploratory objectives include characterisation of PK parameters and evaluation of preliminary efficacy signals using a comprehensive battery of audiological tests (including speech-in-noise performance, pure tone audiometry, and auditory brainstem response), tinnitus assessments, and quality-of-life measures. Patients will be followed for up to approximately 6 months after treatment to assess longer-term safety and durability of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DX243 low flat dose | Experimental | Drug: DX243Flat dose administered sub-cutaneously for 1 month |
| DX243 high flat dose | Experimental | Drug: DX243Flat dose administered sub-cutaneously for 1 month |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered sub-cutaneously for 1 month |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Current tympanic membrane perforation;
- Current acute or chronic otitis;
- Genetic hearing loss;
- Symmetric or asymmetric severe hearing loss;
- Any therapy known as ototoxic;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DX243DX243 10 mg/mL | Drug | DX243 high flat dose, DX243 low flat dose |
| PlaceboPlacebo solution, matching the external appearance of DX243. | Drug | Placebo |
Primary outcome
Safety and tolerability: incidence, nature, severity and causality of treatment emergent adverse events (TEAE) and (Serious) Adverse events (S)(AEs)
Time frame: 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
Time frame: 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
Time frame: For 7 months
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.
Number of Participants With Abnormal ECG Findings
Time frame: For 7 months
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.
6 secondary outcomes
Change in Pure Tone Audiometry
Time frame: For 7 months
Change in speech audiometry
Time frame: For 7 months
Hearing Handicap Inventory for the Elderly- Screening (HHIE-S) questionnaire score
Time frame: For 7 months
Severity of tinnitus
Time frame: For 7 months
Distorsion Product OtoAcoustic Emission (DPOAE)
Time frame: For 7 months
Quality of Life (QoL) assessed using 15iSSQ scale
Time frame: For 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre hospitalier Universitaire de Liège Sart Tilman
Liège, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DX243 in people with Age-related Hearing Loss, run by Dendrogenix at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: incidence, nature, severity and causality of treatment emergent adverse events (TEAE) and (Serious) Adverse events (S)(AEs) (time frame: Through study completion, an average 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.