At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 95 enrolled
Drug / intervention
FX-322 (One Dose) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating FX-322 (One Dose), FX-322 (Two Doses), and 2 other interventions for Sensorineural Hearing Loss and 2 related conditions. Completed, enrolled 95 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartOct 2019
First PostedOct 2019
Primary CompletionOct 2020
Study CompletionDec 2020
TodayJul 2026
First PostedOct 9, 2019
Enrollment StartOct 4, 2019
Primary CompletionOct 6, 2020
Study CompletionDec 17, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.7 years ago
Interventions
FX-322 (One Dose)drug
Patients will receive one dose of FX-322.
FX-322 (Two Doses)drug
Patients will receive two doses of FX-322.
FX-322 (Four Doses)drug
Patients will receive four doses of FX-322.
Placebodrug
Patients will receive Placebo.