Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

Phase 1/2 Completed 22 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing. CGF166 is a recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human Atonal transcription factor (Hath1).

Timeline

Start: 2014-06-23
Primary completion: 2019-12-09
Completion: 2019-12-09

Publications

Plontke SK. Otology Jubilee: 150 years of the Archiv fur Ohrenheilkunde "Where do we come from?--Where are we?--Where are we going?". Eur Arch Otorhinolaryngol. 2015 Jun;272(6):1301-3. doi: 10.1007/s00405-015-3538-4. Epub 2015 Feb 18. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CGF166	Unknown	20 ml	Other
Subject	CGF166	Unknown	30 ml	Other
Subject	CGF166	Unknown	40 ml	Other
Subject	CGF166	Unknown	60 ml	Other

Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

Summary

Timeline

Publications

Drugs

Indications