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

Sponsor

Frequency Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03300687

Collaborator

(none)

Enrollment

Location

Arms

7.7

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Dec 12, 2017

Actual Study Completion Date :

Jan 18, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Plasma Pharmacokinetics [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)
Plasma Pharmacokinetics [Within a 24 hour period after injection]
Peak Plasma Concentration (Cmax)
Cochlear Perilymph Pharmacokinetics [within a 24 hour period after injection]
single time point measurement in each patient of drug in cochlear perilymph

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Eye and Ear Hospital	Melbourne	Victoria	Australia

Sponsors and Collaborators

Frequency Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frequency Therapeutics

ClinicalTrials.gov Identifier:

NCT03300687

Other Study ID Numbers:

FX-322-103

First Posted:

Oct 3, 2017

Last Update Posted:

Apr 12, 2018

Last Verified:

Apr 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hearing Loss

Study Results

No Results Posted as of Apr 12, 2018