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Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

NCT04462198 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-04-01

Study results available
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Summary

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

Conditions

  • Sensorineural Hearing Loss

Interventions

DRUG

PIPE-505

Intratympanic injection

DRUG

Placebo

Intratympanic injection

Sponsors & Collaborators

  • Contineum Therapeutics

    lead INDUSTRY

Principal Investigators

  • Stephen Huhn, MD · Chief Medical Officer, Pipeline Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-06-17
Completion
2021-06-17
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 NCT04462198 on ClinicalTrials.gov