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NCT03616223 · ClinicalTrials.gov registry record · Phase 1
FX-322 in Sensorineural Hearing Loss
A Phase 1 study, sponsored by Frequency Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03616223: Completed Phase 1 study, sponsored by Frequency Therapeutics.
NCT03616223 is a Phase 1 study that has completed, run by Frequency Therapeutics. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616223, a Phase 1 study, has completed, sponsored by Frequency Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.
Primary Outcome
Treatment-emergent adverse events (TEAE) were defined as any untoward medical occurrence in a subject administered study drug that does not necessarily have a causal relationship with the treatment and were collected from the time of first dose through end of study (day 90). In particular, audiometric and otoscopic TEAEs were recorded per the American Speech-Language-Hearing Association (ASHA) guidelines.
Interventions
- DRUG Placebo
- DRUG FX-322
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-07-03 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 1 |
What the finished NCT03616223 record still lists
NCT03616223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03616223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03616223 about?
NCT03616223 is a clinical study titled "FX-322 in Sensorineural Hearing Loss". This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.
What is the current status of trial NCT03616223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-07-03. Estimated completion is 2018-12-18.
What interventions are being tested in trial NCT03616223?
The interventions under investigation include: Placebo (DRUG), FX-322 (DRUG).
Who is sponsoring clinical trial NCT03616223?
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 NCT03616223's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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