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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 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.

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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.

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

FieldValue
Enrollment Target 31 participants
Start Date 2020-11-02
Est. Completion 2021-09-20
Phase Phase 1

Sponsor

Frequency Therapeutics

6 total trials

What the Registry Record Tells You About NCT04629664

The ClinicalTrials.gov registry entry for NCT04629664 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 785-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (96% lower). The listed sponsor is Frequency Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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