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COMPLETED Phase 2

FX-322 in Adults With Acquired Sensorineural Hearing Loss

NCT05086276 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

Interventions

  • DRUG Placebo
  • DRUG FX-322

Study Locations (20)

New York

  • Clinical Trial Site — Albany
  • Clinical Trial Site — Amherst
  • Clinical Trial Site — New York

South Carolina

  • Clinical Trial Site — Charleston
  • Clinical Trial Site — Orangeburg
  • Clinical Trial Site — Spartanburg

California

  • Clinical Trial Site — Fresno
  • Clinical Trial Site — Torrance

Florida

  • Clinical Trial Site — Sarasota
  • Clinical Trial Site — Tampa

Texas

  • Clinical Trial Site — Dallas
  • Clinical Trial Site — Fort Worth

Arizona

  • Clinical Trial Site — Tucson

Colorado

  • Clinical Trial Site — Colorado Springs

Louisiana

  • Clinical Trial Site — Marrero

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2021-10-12
Est. Completion 2022-12-30
Phase Phase 2

Sponsor

Frequency Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05086276

The ClinicalTrials.gov registry entry for NCT05086276 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Frequency Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05086276 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, South Carolina, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05086276 about?

NCT05086276 is a clinical study titled "FX-322 in Adults With Acquired Sensorineural Hearing Loss". This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

What is the current status of trial NCT05086276?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2021-10-12. Estimated completion is 2022-12-30.

What conditions does trial NCT05086276 study?

This clinical trial studies the following conditions: Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05086276?

The interventions under investigation include: Placebo (DRUG), FX-322 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05086276?

This trial is sponsored by Frequency Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05086276 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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