CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
FX-322 +1 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.

Search/NCT03616223
NCT03616223Phase 2Completed
CompareCT.gov

A Phase 1/2 Randomized, Double-blind, Placebo-controlled Single Dose Study at Two Dose Levels of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss

Frequency Therapeutics·interventional·Posted Aug 6, 2018·Updated Nov 14, 2022

In Brief

A Phase 2 clinical trial evaluating FX-322 and Placebo for Sensorineural Hearing Loss. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSensorineural Hearing Loss
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartJul 3, 2018
Primary CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.9 years ago

Interventions

FX-322drug

Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate

Placebodrug

Intratympanic injection