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

NCT ID: NCT03300687

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2018-01-18

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Active

Subjects will receive FX-322 as an intratympanic injection

Group Type: ACTIVE_COMPARATOR

FX-322

Intervention Type: DRUG

intratympanic injection

Placebo

Subjects will receive Placebo as an intratympanic injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

intratympanic injection

Interventions

FX-322

intratympanic injection

Intervention Type: DRUG

Placebo

intratympanic injection

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Frequency Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Victoria Eye and Ear Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

FX-322-103

Identifier Type: -

Identifier Source: org_study_id