Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04629664 · ClinicalTrials.gov registry record · Phase 1
FX-322 in Adults With Severe Sensorineural Hearing Loss
A Phase 1 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss, sponsored by Frequency Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 7
- Study locations
NCT04629664: Completed Phase 1 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss, sponsored by Frequency Therapeutics.
NCT04629664 is a Phase 1 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss that has completed, run by Frequency Therapeutics. The registered enrollment target is 31 participants, below the 785-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04629664, a Phase 1 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss, has completed, sponsored by Frequency Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
Primary Outcome
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Conditions Studied
Interventions
- OTHER Placebo
- DRUG FX-322
Study Locations (7)
Texas
- Clinical Trial Site - San Antonio #1 - San Antonio
- Clinical Trial Site - San Antonio #2 - San Antonio
Michigan
- Clinical Trial Site - Novi
Nebraska
- Clinical Trial Site - Omaha
New York
- Clinical Trial Site - Amherst
South Carolina
- Clinical Trial Site - Orangeburg
Virginia
- Clinical Trial Site - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2021-09-20 |
| Phase | Phase 1 |
What the finished NCT04629664 record still lists
NCT04629664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 785-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Hearing Loss, Sensorineural appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04629664 lists 7 locations in 6 states (Texas, Michigan, Nebraska).
Frequently Asked Questions
What is clinical trial NCT04629664 about?
NCT04629664 is a clinical study titled "FX-322 in Adults With Severe Sensorineural Hearing Loss". This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
What is the current status of trial NCT04629664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2020-11-02. Estimated completion is 2021-09-20.
What conditions does trial NCT04629664 study?
This clinical trial studies the following conditions: Hearing Loss, Sensorineural, Noise-induced Hearing Loss, Sudden Hearing Loss.
What interventions are being tested in trial NCT04629664?
The interventions under investigation include: Placebo (OTHER), FX-322 (DRUG).
Who is sponsoring clinical trial NCT04629664?
This trial is sponsored by Frequency Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04629664 being conducted?
This trial has 7 study locations across Michigan, Nebraska, New York, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss, Sensorineural
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04629664's enrollment target sits among peer trials
31 15th of 20 higher than 6 of 20 other Hearing Loss, Sensorineural trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss, Sensorineural trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
RECRUITING · NA
-
Barriers and Facilitators to OTC Hearing Aids Success
RECRUITING · NA
-
Preschool Hearing Screening
RECRUITING · NA
-
Listening Effort in Cochlear Implant Users
RECRUITING · NA
-
Post-Market Clinical Investigation of the IotaSOFT Insertion System
RECRUITING
-
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI