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NCT04120116 · ClinicalTrials.gov registry record · Phase 2
FX-322 in Adults With Stable Sensorineural Hearing Loss
A Phase 2 study, sponsored by Frequency Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT04120116: Completed Phase 2 study, sponsored by Frequency Therapeutics.
NCT04120116 is a Phase 2 study that has completed, run by Frequency Therapeutics. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04120116, a Phase 2 study, has completed, sponsored by Frequency Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
Primary Outcome
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Interventions
- DRUG Placebo
- DRUG FX-322 (One Dose)
- DRUG FX-322 (Two Doses)
- DRUG FX-322 (Four Doses)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2019-10-04 |
| Est. Completion | 2020-12-17 |
| Phase | Phase 2 |
What the finished NCT04120116 record still lists
NCT04120116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04120116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04120116 about?
NCT04120116 is a clinical study titled "FX-322 in Adults With Stable Sensorineural Hearing Loss". This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
What is the current status of trial NCT04120116?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2019-10-04. Estimated completion is 2020-12-17.
What interventions are being tested in trial NCT04120116?
The interventions under investigation include: Placebo (DRUG), FX-322 (One Dose) (DRUG), FX-322 (Two Doses) (DRUG), FX-322 (Four Doses) (DRUG).
Who is sponsoring clinical trial NCT04120116?
This trial is sponsored by Frequency Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04120116's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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