A Phase 1b, Multicenter, Double-blind, Randomized, Placebo-controlled, Single Ascending-Dose, Clinical Study Evaluating the Safety, Tolerability and Exploratory Efficacy of a Targeted Single Injection of an Intradiscal Nuclear Factor-κB Decoy Oligodeoxynucleotide (AMG0103) in Subjects With Chronic Discogenic Lumbar Back Pain
Not yet recruiting
Phase of Trial: Phase I
Latest Information Update: 31 Aug 2017
At a glance
- Drugs NF kappa B Decoy-AnGes MG (Primary)
- Indications Back pain
- Focus Adverse reactions
- Sponsors AnGes MG
- 24 Aug 2017 Status changed from planning to not yet recruiting.
- 25 Apr 2017 According to an AnGes media release, the US FDA has cleared the IND application for NF-kappaB decoy oligo DNA (NF-kappaB decoy) for the treatment of discogenic lower back pain (DLBP). The company plans to initiate a phase Ib clinical trial from the middle of this year at several clinical sites including University of California San Diego.
- 24 Mar 2017 According to an AnGes media release, the company has submitted an IND application to the US FDA for initiating this trial.