First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation

Early Phase 1

Completed

• Conditions: Hearing Loss
• Interventions: Drug: FX-322; Drug: Placebo

• Registration Number: NCT03300687
• Lead Sponsor: Frequency Therapeutics

Brief 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.

Study Timeline

• Study Start: 2017-05-30
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-03
• Primary Completion: 2017-12-12
• Study Completion: 2018-01-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery.
2. Willingness and ability to comply with scheduled visits, ear examination, drug administration plan, auditory and laboratory tests, study restrictions, and all study procedures.

Other protocol-defined inclusion criteria may apply

Exclusion Criteria

1. Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection.
2. Any conductive component defined as air-bone gaps >10 dB at two or more frequencies.

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	FX-322	Subjects will receive FX-322 as an intratympanic injection
Placebo	Placebo	Subjects will receive Placebo as an intratympanic injection

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.	Treatment-emergent adverse events will be assessed over a several hour to two week period	To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.

Secondary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetics	Within a 24 hour period after injection	Peak Plasma Concentration (Cmax)
Cochlear Perilymph Pharmacokinetics	within a 24 hour period after injection	single time point measurement in each patient of drug in cochlear perilymph

Trial Locations

Locations (1)

Royal Victoria Eye and Ear Hospital; 🇦🇺 Melbourne, Victoria, Australia