NCT04208087

PK and Safety of SI-722 in IC/BPS

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Seikagaku Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.

Conditions

• Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	SI-722	SI-722 will be intravesically instilled.
DRUG	Placebo	Placebo will be intravesically instilled.

Timeline

• Start date: 2020-03-30
• Primary completion: 2021-01-12
• Completion: 2021-01-12
• First posted: 2019-12-23
• Last updated: 2023-12-29
• Results posted: 2023-12-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study