MedTrace Logo

First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

NCT05664100 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-04-27

No results posted yet for this study

Summary

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

Conditions

  • Hearing Loss, Sensorineural

Interventions

DRUG

FX-345

Single intratympanic injection of FX-345

DRUG

Placebo

Single intratympanic injection of placebo

Sponsors & Collaborators

  • Frequency Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carl LeBel, PhD · Frequency Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-04-12
Completion
2023-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664100 on ClinicalTrials.gov