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

Primary Purpose

Hearing Loss

Status

Completed

Phase

Early Phase 1

Locations

Australia

Study Type

Interventional

Intervention

FX-322

Placebo

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Royal Victoria Eye and Ear Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Subjects will receive FX-322 as an intratympanic injection

Subjects will receive Placebo as an intratympanic injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Plasma Pharmacokinetics

Peak Plasma Concentration (Cmax)

Cochlear Perilymph Pharmacokinetics

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

Full Information

NCT ID

NCT03300687

First Posted

September 15, 2017

Last Updated

April 11, 2018

Sponsor

Frequency Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03300687

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

May 30, 2017 (Actual)

Primary Completion Date

December 12, 2017 (Actual)

Study Completion Date

January 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Frequency Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Active Comparator

Arm Description

Subjects will receive FX-322 as an intratympanic injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will receive Placebo as an intratympanic injection

Intervention Type

Drug

Intervention Name(s)

FX-322

Intervention Description

intratympanic injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

intratympanic injection

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Plasma Pharmacokinetics

Description

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

Title

Plasma Pharmacokinetics

Description

Peak Plasma Concentration (Cmax)

Time Frame

Within a 24 hour period after injection

Title

Cochlear Perilymph Pharmacokinetics

Description

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

Time Frame

within a 24 hour period after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Royal Victoria Eye and Ear Hospital

City

Melbourne

State/Province

Victoria

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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