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NCT04601909 · ClinicalTrials.gov registry record · Phase 1

FX-322 in Adults With Age-Related Sensorineural Hearing Loss

A Phase 1 study, sponsored by Frequency Therapeutics.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT04601909: Completed Phase 1 study, sponsored by Frequency Therapeutics.

NCT04601909 is a Phase 1 study that has completed, run by Frequency Therapeutics. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04601909, a Phase 1 study, has completed, sponsored by Frequency Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

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 age-related sensorineural hearing loss.

Primary Outcome

Number of patients with treatment-related adverse events assessed by CTCAE v5.0

Interventions

  • OTHER placebo
  • DRUG FX-322

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-09-17
Est. Completion 2022-05-16
Phase Phase 1
Frequency Therapeutics

6 total trials

What the finished NCT04601909 record still lists

NCT04601909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT04601909 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04601909 about?

NCT04601909 is a clinical study titled "FX-322 in Adults With Age-Related 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 age-related sensorineural hearing loss.

What is the current status of trial NCT04601909?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-09-17. Estimated completion is 2022-05-16.

What interventions are being tested in trial NCT04601909?

The interventions under investigation include: placebo (OTHER), FX-322 (DRUG).

Who is sponsoring clinical trial NCT04601909?

This trial is sponsored by Frequency Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04601909's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT04601909, the US trial registry maintained by the National Library of Medicine. NCT04601909 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.