Overview

Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer

Status:
Completed
Trial end date:
2018-02-17
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the safety of a single treatment of hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections. Two dose levels (16000 µg and 24000 µg; 20 or 30 bladder wall injections, respectively) in females with moderate Overactive Bladder/Detrusor overactivity (OAB/DO) of ≥6 months duration will be evaluated. In each dose level, 6 participants will receive hMaxi-K and 3 will receive placebo.
Phase:
Phase 1
Details
Lead Sponsor:
Ion Channel Innovations
Urovant Sciences GmbH
Collaborator:
Ion Channel Innovations