NCT03246399

A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease

A Phase 1, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135, and 180.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	SM04690	suspension formulation of SM04690, delivered via intradiscal injection (single injection)

Timeline

• Start date: 2017-07-26
• Primary completion: 2018-11-14
• Completion: 2018-12-04
• First posted: 2017-08-11
• Last updated: 2019-04-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study