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

Early Phase 1CompletedNCT03300687

Frequency Therapeutics9 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Hearing Loss

Interventions

FX-322DRUG

intratympanic injection

PlaceboDRUG

intratympanic injection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Royal Victoria Eye and Ear Hospital

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.

To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.

Time frame: Treatment-emergent adverse events will be assessed over a several hour to two week period

Secondary Outcomes

Plasma Pharmacokinetics

Drug exposure in the systemic circulation by evaluating Cmax and AUC Drug exposure evaluated by area under the plasma concentration versus time curve (AUC)

Time frame: Systemic exposure will be evaluated over a 72 hour period

Plasma Pharmacokinetics

Peak Plasma Concentration (Cmax)

Time frame: Within a 24 hour period after injection

Cochlear Perilymph Pharmacokinetics

single time point measurement in each patient of drug in cochlear perilymph

Time frame: within a 24 hour period after injection

Data from ClinicalTrials.gov

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