A Phase 1b, Open-label, Single-Arm Study Evaluating the Safety and Efficacy of GLX-100 in Subjects with Interstitial Cystitis/Painful Bladder Syndrome

  • Rosamilia, Anna (Primary Chief Investigator (PCI))

Project: Research

Project Details

Project Description

The purpose of this research is to test the safety and tolerability of GLX-100 in subjects with IC/PBS. GLX-100 is a new and novel glycosaminoglycan (GAG) designed to coat the defective urothelial layer in the bladder in order to restore impermeability to the bladder which can reduce irritation caused by compounds found in the urine. This study will enrol approximately 40 subjects with IC/BPS at approximately 8 sites. GLX-100 will be administered to subjects once per week for 8 weeks.

ERM Reference Number: HREC/92405/MonH-2023-350647(v1)

Monash Health Local Reference: RES-23-0000-040A
StatusActive
Effective start/end date31/08/2330/08/28

Keywords

  • device
  • interstitial cystitis
  • painful bladder syndrome