Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Public ClinicalTrials.gov record NCT04462198. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Unilateral Intratympanic PIPE-505 in Subjects With Sensorineural Hearing Loss Associated With Speech-in-Noise Impairment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
Study identification
- NCT ID
- NCT04462198
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 15, 2020 (Actual)
- Primary completion
- Jun 17, 2021 (Actual)
- Completion
- Jun 17, 2021 (Actual)
- Last update posted
- Apr 1, 2025
2020 – 2021
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Breathe Clear Institute | Torrance | California | 90503 | — |
| ENT and Allergy Associates of Florida | Boca Raton | Florida | 33487 | — |
| Advanced ENT & Allergy | New Albany | Indiana | 47150 | — |
| University of Kansas; Dept of Otolaryngology Head & Neck Surgery | Kansas City | Kansas | 66160 | — |
| Advanced ENT & Allergy | Louisville | Kentucky | 40220 | — |
| Charlotte Eye Ear Nose Throat Associates | Charlotte | North Carolina | 28210 | — |
| Piedmont Ear Nose Throat and Associates | Winston-Salem | North Carolina | 27103 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04462198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 1, 2025 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04462198 live on ClinicalTrials.gov.