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Completed

NCT Number: NCT03300687

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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Royal Victoria Eye and Ear Hospital

Melbourne, Victoria, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.
  • Any conductive component defined as air-bone gaps >10 dB at two or more frequencies.

Other protocol-defined exclusion criteria may apply

Treatment and study plan

FX-322

Drug

intratympanic injection

Placebo

Drug

intratympanic injection

Primary outcomes

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

    Time frame: 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 outcomes

  1. Plasma Pharmacokinetics

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

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

  2. Plasma Pharmacokinetics

    Time frame: Within a 24 hour period after injection

    Peak Plasma Concentration (Cmax)

  3. Cochlear Perilymph Pharmacokinetics

    Time frame: within a 24 hour period after injection

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

Sponsors and collaborators

Lead sponsor

Frequency Therapeutics

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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