Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CGF166 · 1 trial · 1 indication
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...
CGF166 is an investigational small molecule being developed for the treatment of unilateral or bilateral severe to profound hearing loss. It is intended for patients with this condition, which involves significant hearing impairment in one or both ears.
CGF166 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
CGF166 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
CGF166 has been studied in one clinical trial with the identifier NCT02132130. This Phase 1 trial, titled 'Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss,' has been completed. The trial enrolled 22 participants in the United States.
CGF166 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available information.