Trials / Completed
CompletedNCT04120116
FX-322 in Adults With Stable Sensorineural Hearing Loss
A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Frequency Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
Detailed description
Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. This phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96 subjects with stable mild to moderately severe sensorineural hearing loss, with a medical history consistent with either excessive noise exposure or idiopathic sudden sensorineural hearing loss.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FX-322 (One Dose) | Patients will receive one dose of FX-322. |
| DRUG | FX-322 (Two Doses) | Patients will receive two doses of FX-322. |
| DRUG | FX-322 (Four Doses) | Patients will receive four doses of FX-322. |
| DRUG | Placebo | Patients will receive Placebo. |
Timeline
- Start date
- 2019-10-04
- Primary completion
- 2020-10-06
- Completion
- 2020-12-17
- First posted
- 2019-10-09
- Last updated
- 2023-04-27
- Results posted
- 2023-04-27
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04120116. Inclusion in this directory is not an endorsement.