Trials / Completed
CompletedNCT03300687
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Frequency Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.
Detailed description
Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FX-322 | intratympanic injection |
| DRUG | Placebo | intratympanic injection |
Timeline
- Start date
- 2017-05-30
- Primary completion
- 2017-12-12
- Completion
- 2018-01-18
- First posted
- 2017-10-03
- Last updated
- 2018-04-12
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03300687. Inclusion in this directory is not an endorsement.