NCT03055845

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

A Prospective, Randomised, Double-blinded, Placebo-controlled, Single Ascending Dose Study Investigating the Safety and Local Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Stayble Therapeutics · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	STA363	STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
DRUG	Placebo	Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.

Timeline

• Start date: 2017-03-27
• Primary completion: 2019-08-29
• Completion: 2019-08-29
• First posted: 2017-02-16
• Last updated: 2020-02-18

Locations

1 site across 1 country: Sweden