ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    FX-322

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03300687
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hearing Loss Drug: FX-322 Drug: Placebo Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Subjects will receive FX-322 as an intratympanic injection
Drug: FX-322
intratympanic injection

Placebo Comparator: Placebo
Subjects will receive Placebo as an intratympanic injection
Drug: Placebo
intratympanic injection




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300687


Locations
Australia, Victoria
Royal Victoria Eye and Ear Hospital
Melbourne, Victoria, Australia
Sponsors and Collaborators
Frequency Therapeutics

Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT03300687     History of Changes
Other Study ID Numbers: FX-322-103
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms