A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

Summary

A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain. 15 patients will participate in either of 3 dose groups, each comprising 5 patients: * Group 1: STA363 dose 1 (3 patients) or placebo (2 patients) * Group 2: STA363 dose 2 (3 patients) or placebo (2 patients) * Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)

Timeline

Start

2017-03-27

Primary completion

2019-08-29

Completion

2019-08-29

Drugs

Indications

No indication recorded.