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NCT05664100 · ClinicalTrials.gov registry record · Phase 1
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
A Phase 1 study, sponsored by Frequency Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05664100: Clinical Trial Phase 1 study, sponsored by Frequency Therapeutics.
NCT05664100 is a Phase 1 study that was terminated before completion, run by Frequency Therapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05664100, a Phase 1 study, was terminated before completion, sponsored by Frequency Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.
Interventions
- DRUG Placebo
- DRUG FX-345
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2023-04-12 |
| Phase | Phase 1 |
Why NCT05664100 stopped before completion
NCT05664100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05664100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05664100 about?
NCT05664100 is a clinical study titled "First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss". This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile...
What is the current status of trial NCT05664100?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-12-15. Estimated completion is 2023-04-12.
What interventions are being tested in trial NCT05664100?
The interventions under investigation include: Placebo (DRUG), FX-345 (DRUG).
Who is sponsoring clinical trial NCT05664100?
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 NCT05664100's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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