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Clinical Trial Summary

This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.


Clinical Trial Description

This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other audiological tests. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04462198
Study type Interventional
Source Pipeline Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 15, 2020
Completion date June 17, 2021

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