First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss
Recruiting
Phase 2
Interventional Study
Age-related Hearing Loss
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Dendrogenix · Industry
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About This Trial
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 fla…
Trial Locations
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Eligibility Criteria
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…
Contacts
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