Cochlear SynaptopathyPhase 1/2RESPLANDNCT07472907
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
A Phase 1/2 study testing CIL001 (Paliroden) in people with Cochlear Synaptopathy, run by Cilcare SAS.
Trial summary
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes. Neuroinflammation in diabetes can cause auditory nerve damage (cochlear synaptopathy) which first translates into speech-in-noise intelligibility deficit. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cochlear Synaptopathy
- What is being tested?
- CIL001 (Paliroden)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jul 2028
- Phase
- Phase 1/2
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Aged between 45 and 75 years old (inclusive) at the time of screening
- Established type 2 diabetes as determined by 7% ≤ hemoglobin A1c (HbA1c) ≤ 9% and diabetes duration of at least 5 years
- Be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator
- Participants must be native speakers of the official language(s) of the country in which the study assessments are conducted.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study. In addition, they must agree to use highly effective contraception methods, as defined by regulatory guidance (e.g., combined hormonal contraception, intrauterine device, or surgical sterilization), from the screening visit, for the duration of study treatment and for 30 days after dosing.
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- The following audiology assessments, if not performed on the same day as the review of the previous criteria (e.g., when the participant's first visit does not take place at the ENT site), may be scheduled on different days within a maximum interval of 14 days after the first screening visit and must be completed at least 21 days before the baseline visit.
- Normal hearing as defined by PTAv (0.5-1-2kHz-4Khz) <25dB in both ears.
- Up to mild hearing loss in the high-frequency range (PTAvHF (4-6-8kHz) <40dB) in both ears.
- Speech-in-noise deficit (at least 3dB SNR loss in comparison to normative value of the Matrix test) in both ears.
Who cannot join
- MoCA score < 26
- Known otologic pathology (e.g., History of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, or Menière's disease in either ear)
- Presence of middle ear pathology (e.g., otitis media, tympanic membrane perforation, etc.)
- History of platinum-based chemotherapy
- Previous or concurrent malignancies that require treatment and are not clinically stable
- Current evidence or history of retrocochlear pathology (e.g., acoustic neuroma)
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- History of otologic surgery (apart from tympanostomy tube insertion if more than one year prior to inclusion visit)
- Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (e.g., cerumen ear plug, ear drum perforation). In case of cerumen plugs not affecting the hearing results, a removal must be scheduled before V1 (baseline/inclusion).
- Hearing aids and cochlear implants.
- History of cancer treated by platinum-based chemotherapy.
- Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential, or planning to become pregnant during the study
- Liver Enzyme Lab Outcomes:
- Bilirubin > 2 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST/ALT) >5 times ULN.
- Gamma glutamyltransferase (GGT) > 5 times ULN
- Maternally Inherited Diabetes
- Congenital hearing loss
- Untreated hypothyroidism
- Adult individual under legal protection as defined by applicable regulations (e.g., persons deprived of liberty, hospitalized without consent, unable to provide informed consent, or placed under legal guardianship or curatorship)
- Concurrent participation in another clinical study or participation in another trial involving experimental drug within 30 days or five half-lives of the experimental drug (whichever was longer) prior to screening visit (V0).
- Diagnosed anxiety disorders, psychosis, depression, schizophrenia, attempted suicide, or other significant psychiatric conditions that could impact their ability to cooperate and comply with the study protocol
- Major surgery that may impact the study conduct or outcomes within eight weeks before screening or scheduled/planned surgery within the time frame of the study
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Volume Phase 1B/2A Clinical Trial to Investigate the Safety and Efficacy of a Single Transtympanic Injection of CIL001 (Paliroden) for the Treatment of Cochlear Synaptopathy in Participants With type2 Diabetes
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes. Neuroinflammation in diabetes can cause auditory nerve damage (cochlear synaptopathy) which first translates into speech-in-noise intelligibility deficit. CIL001 is a neurotrophic small molecule that aims to repair auditory nerve when applied locally by transtympanic injection. Transtympanic injection of paliroden is anticipated to improve the symptoms of cochlear synaptopathy. Furthermore, by addressing auditory or vestibular dysfunction early and effectively, this approach may contribute to limiting or delaying, over the long term, the onset of secondary neurological disorders, such as dementia.
- Conditions
- Cochlear Synaptopathy
- Being tested
- CIL001 (Paliroden), Placebo
- Keywords
- hearing, diabetes
- Medical subject headings
- Hearing Loss, Hidden, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIL001 (Paliroden)Drug
Single unilateral transtympanic administration
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CIL001 | Experimental | Single Unilateral transtympanic administration Receives: Drug: CIL001 (Paliroden) |
| Placebo | Placebo comparator | Single Unilateral transtympanic administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology
Measured: Over 6 month (168 days) post-injection
Secondary outcomes (5)
Determine the concentration in plasma of paliroden with Area under the plasma concentration versus time curve (AUC)
Measured: From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)
Measured: From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Time to maximum concentration (Tmax)
Measured: From the day of injection to 28 days
Change in speech in noise intelligibility base on the SRT50 result From the Matrix test (SRT50 = Signal-to-noise ratio required to correctly understand 50% of presented speech)
Measured: At Day 84 from baseline
Change in ABR Wave I amplitude (µV) measured by electrocochleography
Measured: Day 28, Day 84, Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear SynaptopathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, sequential , ascending volume design, two arms, with up to three cohorts
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cilcare SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472907
- Sponsor's protocol ID
- RESPLAND
- Other IDs
- 2025-524383-37-00, 2025
- Acronym
- RESPLAND
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Volume Phase 1B/2A Clinical Trial to Investigate the Safety and Efficacy of a Single Transtympanic Injection of CIL001 (Paliroden) for the Treatment of Cochlear Synaptopathy in Participants With type2 Diabetes
- ClinicalTrials.gov ID
- NCT07472907
- Acronym / sponsor ID
- RESPLAND / RESPLAND
- Conditions
- Cochlear Synaptopathy
- Keywords
- hearing, diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Cilcare SASIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 16 Mar 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.
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes. Neuroinflammation in diabetes can cause auditory nerve damage (cochlear synaptopathy) which first translates into speech-in-noise intelligibility deficit. CIL001 is a neurotrophic small molecule that aims to repair auditory nerve when applied locally by transtympanic injection. Transtympanic injection of paliroden is anticipated to improve the symptoms of cochlear synaptopathy. Furthermore, by addressing auditory or vestibular dysfunction early and effectively, this approach may contribute to limiting or delaying, over the long term, the onset of secondary neurological disorders, such as dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, sequential , ascending volume design, two arms, with up to three cohorts
| Arm | Type | Receives |
|---|---|---|
| CIL001 | Experimental | Drug: CIL001 (Paliroden)Single Unilateral transtympanic administration |
| Placebo | Placebo comparator | Drug: PlaceboSingle Unilateral transtympanic administration |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated informed consent form
- Aged between 45 and 75 years old (inclusive) at the time of screening
- Established type 2 diabetes as determined by 7% ≤ hemoglobin A1c (HbA1c) ≤ 9% and diabetes duration of at least 5 years
- Be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator
- Participants must be native speakers of the official language(s) of the country in which the study assessments are conducted.
Key exclusion criteria (22 listed)
- MoCA score < 26
- Known otologic pathology (e.g., History of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, or Menière's disease in either ear)
- Presence of middle ear pathology (e.g., otitis media, tympanic membrane perforation, etc.)
- History of platinum-based chemotherapy
- Previous or concurrent malignancies that require treatment and are not clinically stable
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 |
|---|---|---|
| CIL001 (Paliroden)Single unilateral transtympanic administration | Drug | CIL001 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology
Time frame: Over 6 month (168 days) post-injection
5 secondary outcomes
Determine the concentration in plasma of paliroden with Area under the plasma concentration versus time curve (AUC)
Time frame: From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)
Time frame: From the day of injection to 28 days
Determine the concentration in plasma of paliroden with Time to maximum concentration (Tmax)
Time frame: From the day of injection to 28 days
Change in speech in noise intelligibility base on the SRT50 result From the Matrix test (SRT50 = Signal-to-noise ratio required to correctly understand 50% of presented speech)
Time frame: At Day 84 from baseline
Change in ABR Wave I amplitude (µV) measured by electrocochleography
Time frame: Day 28, Day 84, Day 168
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cochlear Synaptopathy
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RecruitingObservational study
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Hidden Hearing Loss
Recruiting
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CIL001 (Paliroden) in people with Cochlear Synaptopathy, run by Cilcare SAS.
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 10 inclusion and 22 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology (time frame: Over 6 month (168 days) post-injection). 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 26 Oct 2026.