NCT03263611

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: AnGes, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted single injection of AMG0103 in subject with chronic discogenic lumbar back pain

Detailed description

This is a Phase 1b, multicenter, double-blind, single ascending dose study designed to evaluate the safety of AMG0103 in adult male and female subjects with chronic discogenic lumbar back pain. This protocol anticipates that 8 subjects with symptomatic single level discogenic pain will be enrolled in each of up to 3 dose-escalation cohorts. Subjects in each cohort will receive AMG0103 or Placebo as a targeted, single, intradiscal injection.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	Placebo	single intradiscal injection
DRUG	AMG0103	single intradiscal injection

Timeline

• Start date: 2018-02-26
• Primary completion: 2021-02-15
• Completion: 2021-02-15
• First posted: 2017-08-28
• Last updated: 2021-10-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study