Overview

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

Status:
Completed
Trial end date:
2019-08-29
Target enrollment:
Participant gender:
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)
Phase:
Phase 1
Details
Lead Sponsor:
Stayble Therapeutics