Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04462198 | Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss | PHASE1 | COMPLETED | 28 | — | — | Oct 15, 2020 | Jun 17, 2021 | Apr 1, 2025 | 8 | United States |
Number of participants with TEAEs
| Arm | Type | Description |
|---|---|---|
| PIPE-505 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PIPE-505 | DRUG | Intratympanic injection |
| Placebo | DRUG | Intratympanic injection |
Inclusion Criteria: * Subject's primary language is English. * Male or female between 18 and 75 years of age, inclusive, at randomization. * Diagnosis of bilateral sensorineural hearing loss (SNHL). * Normal tympanogram in the ear intended for injection (as defined in protocol) at Screening. * Male...