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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300687
• Other study ID #: FX-322-103
• Status: Completed
• Phase: Early Phase 1
• First received: September 15, 2017
• Last updated: April 11, 2018
• Start date: May 30, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: April 2018
• Source: Frequency Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 18, 2018
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Drug:
• FX-322
intratympanic injection
• Placebo
intratympanic injection

Locations

Country	Name	City	State
Australia	Royal Victoria Eye and Ear Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Frequency Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Treatment-emergent adverse events will be assessed over a several hour to two week period
Secondary	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)	Systemic exposure will be evaluated over a 72 hour period
Secondary	Plasma Pharmacokinetics	Peak Plasma Concentration (Cmax)	Within a 24 hour period after injection
Secondary	Cochlear Perilymph Pharmacokinetics	single time point measurement in each patient of drug in cochlear perilymph	within a 24 hour period after injection