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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 is a Phase 1 study that was terminated before completion, run by Frequency Therapeutics. The registered enrollment target is 6 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05664100
The ClinicalTrials.gov registry entry for NCT05664100 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Frequency Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05664100 reports 0 study locations.
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.
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