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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02132130 | Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss | PHASE1 | COMPLETED | 22 | — | — | Jun 23, 2014 | Dec 9, 2019 | Oct 8, 2021 | 4 | United States |
AE tables are below in the Adverse Events section of this report.
AE tables are below in the Adverse Events section of this report.
Summary of pure tone audiometry air conduction thresholds at frequency 0.125 KHz
Summary of pure tone audiometry bone conduction thresholds by time and frequency 0.250 KHz
Summary of change from baseline in pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
Summary of change from baseline in Non-treated ear's pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
| Arm | Type | Description |
|---|---|---|
| CGF166 dose 20 uL | EXPERIMENTAL | single dose volume #1 |
| CGF166 dose 30 and 40 uL | EXPERIMENTAL | single dose volume #2 |
| CGF166 dose 40 uL | EXPERIMENTAL | single dose volume #3 |
| CGF166 dose 60 uL | EXPERIMENTAL | single dose volume #4 |
| CFG166 dose 30 uL | EXPERIMENTAL | Single dose volume #5 |
| Name | Type | Description |
|---|---|---|
| CGF166 | DRUG | CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion |
For all Parts A, B and C of the study, Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. For all Parts A, B and C of the study, male or female patients, 18 to 75 years old, inclusive, with severe-to-profound bilateral hearing loss or unilateral...